Mayo Clinic researchers have found that bipolar disorder (BPD) is a more costly chronic condition than asthma and coronary artery disease (CAD), based on a review of health care claim costs. Specialty care costs (the costs of seeing any specialist and all tests ordered) were especially higher for bipolar patients. Results of this review were presented at the Annual Meeting of the American Psychiatric Association in San Francisco.

“Psychiatric care costs represented only a portion of the specialty care costs for these chronic conditions, explains Mark Williams, M.D., a Mayo Clinic psychiatrist and lead researcher. This suggests that many of the specialty costs for bipolar patients are not directly related to seeing a mental health provider.”
A data review of health care claims over a four-year period, showed patients with BPD had significantly higher total per member per month costs when compared with the other groups. Only patients with both CAD and diabetes had higher costs than patients with BPD. Total costs, specialty care visits, specialty care costs, outpatient psychiatric costs and outpatient psychiatric visits were compared.

Source:
John Murphy

Mayo Clinic

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Study results suggest that abnormalities in perigenual anterior cingulate cortex (pACC) “amygdala functional connectivity occur during emotional processing in bipolar disorder (BD).

The pACC and amygdala are critical components of emotional processing circuitry and share extensive interconnections.

“Taken together, these data provide some of the first evidence that abnormalities in the structural integrity of white matter may contribute to disruptions in the coordinated response of the pACC and amygdale to emotional stimuli in BD,” say Fei Wang (Yale University, New Haven, Connecticut, USA) and co-authors.

The researchers performed functional magnetic resonance imaging (fMRI) during processing of an event-related emotional face task and diffusion tensor imaging (DTI) on 33 patients with BD and 31 healthy controls.

When comparing the strength of the pACC “amygdala functional connections between the groups, the authors found that functional connectivity was significantly decreased in the BD during the processing of fearful and happy faces. No significant group differences were seen during neutral face processing.

Wang et al also found a significant positive association between the pACC “amygdala functional coupling during fearful and happy face processing and fractional anisotropy (FA) values in the region of the uncinate fasciculus and neighboring ventrofrontal white matter, regions of fronto-thalamo-striatal projections, as well as frontotemporal projections to the posterior association cortex.

Furthermore, FA values were significantly decreased in the BD group compared with the control group.

“The decrease in pACC “amygdala functional connectivity in BD could reflect a reduction in the pACC’s inhibitory control over the amygdala,” writes the team in the journal Biological Psychiatry.

However no group differences in amygdala activation were seen between the groups despite the significant decreases in pACC “amygdala connectivity, which the authors say is unclear.

The researchers call for further study of gray-white matter relationships and their associations to pACC “amygdala functional connectivity disruptions. They suggest that since the ACC receives a progressive and extensive growth of fibers originating from the amygdale during adolescence, further studies during this period could help elucidate a neurodevelopmental mechanism contributing to the disorder.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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Bipolar disorder patients who have a first affective episode with psychotic symptoms and a history of mania have a semantic verbal fluency deficit that occurs in spite of generally preserved function, say UK scientists.

Bipolar disorder patients have memory, attention, and executive function deficits that persist during euthymia. While such deficits are correlated with the number of prior affective episodes, they have also been demonstrated in first-episode patients.

To examine the extent to which such deficits represent “core” bipolar disorder characteristics, Eugenia Kravariti, from King’s College London, and colleagues administered, among other tests, a neuropsychological battery to 35 bipolar disorder patients with a first affective episode showing psychotic symptoms and a positive history of mania and 274 community controls.

In addition, a subanalysis was performed between the patients and 105 controls matched for current IQ (”good” versus “poor”) and IQ trajectory (”stable,” “declined,” and “improved”).

There were no differences between patients and either groups of controls in terms of gender, education, or National Adult Reading Test IQ, whereas there were significant differences in age and ethnicity.

The results, published in the journal Bipolar Disorders, show that there was evidence of a suggested deficit in patients compared with controls on the Rey Auditory Verbal Learning Test Trial 6, and a significant deficit in patients compared with controls in semantic fluency.

Only the latter deficit was detectable in patents compared with IQ-matched controls. Compared with the overall control group, semantic fluency had a medium effect size, and a small-to-medium effect size compared with IQ-matched controls. There were no other significant deficits.

Further analysis demonstrated that antipsychotic medication had a small and nonsignificant negative correlation with semantic fluency, at average scores of 34.78 in medicated cases versus 45.00 in two non-medicated patients.

The team writes: “In summary, our results point to a moderate, isolated impairment in semantic verbal fluency in patients with a first affective episode with psychotic symptoms and a positive history of mania.

“This pattern contrasts sharply with the widespread neuropsychological dysfunction seen in the early phases of schizophrenia.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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People who develop bipolar disorder in childhood or adolescence are at greater risk for recurrence, chronicity of mood symptoms, and functional impairment than those who develop the mood disorder in adulthood, US study results confirm.

“Symptoms of bipolar disorder are increasingly recognized among children and adolescents,” explain Roy Perlis (Massachusetts General Hospital and Harvard Medical School, Boston, USA), and colleagues.

But they add: “Little is known about the course of bipolar disorder among adults who experience childhood onset of symptoms.”

To investigate, the researchers studied data on 3658 adult patients with bipolar I and II disorder who were participating the Systematic Treatment Enhancement Program for Bipolar Disorder ??” a multicenter clinical effectiveness study.

The participants were divided into three groups based on age at disease onset of less than 13 years (childhood or prepubertal onset), 13??”18 years (adolescent onset) and over 18 years (adult onset).

Baseline features and outcomes over 2 years of follow-up were compared among the three groups.

The team found that, compared with the 1187 patients with adult onset bipolar disorder, the 1068 patients with childhood or prepubertal onset of disease experienced, on average, an earlier recurrence of mood episodes after initial remission, fewer days of euthymia, and greater impairment in functioning and quality of life over follow-up.

Patients with adolescent onset bipolar disorder (n=1403) also had poorer outcomes than those with adult-onset disease, but better outcomes than those with childhood or prepubertal onset bipolar disorder.

Writing in the journal Bipolar Disorders, Perlic and team conclude: “These results… suggest that individuals with earlier onset [bipolar disorder] may be at risk for a more chronic as well as recurrent course in adulthood, with poorer functioning and quality of life.”

They add that the findings “underscore the need to develop better strategies for early identification and early interventions which achieve and maintain symptomatic remission and enhance functioning over the course of development.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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Results presented today at the 162nd American Psychiatric Association (APA) congress in San Francisco, CA, demonstrated the efficacy and tolerability of SEROQUEL® (quetiapine fumarate) for treating depressive episodes in bipolar disorder, including the difficult-to-treat bipolar II patient population.1,2 The data are from combined analyses of four large-scale clinical trials to examine SEROQUEL as a treatment for depressive episodes associated with bipolar I and II disorders. SEROQUEL and SEROQUEL XR™, a once-daily, extended-release formulation of SEROQUEL, is one of the most widely studied atypical antipsychotic in bipolar depression and the only agent approved as monotherapy to treat the spectrum of mood episodes associated with bipolar disorder.

“Bipolar disorder is a chronic illness with patients experiencing severe debilitating mood swings. Patients spend a majority of their time ill in the depressed phase of the illness. These important findings confirm that SEROQUEL is an effective agent for the treatment of bipolar depression, and particularly encouraging are the results in bipolar II patients who historically have not responded well to treatment,” said Professor Alan Young of the Department of Psychiatry, University of British Columbia, Vancouver, Canada.

Results from a combined analysis of all patients with bipolar I or II disorder (n=2593) demonstrated that SEROQUEL monotherapy was significantly more effective than placebo for treating depressive episodes associated with bipolar disorder as measured by improvements in the Montgomery-?sberg Depression Rating Scale (MADRS) total score (P<0.001 for both doses of SEROQUEL). Similar results were observed in a combined analysis of patients with bipolar II disorder (n=819). In both analyses, improvements were evident as early as week 1 and continued through week 8. The four studies, BOLDER (BipOLar DEpRession) I and II and EMBOLDEN (Efficacy of quetiapine Monotherapy in BipOLar DEpressioN) I and II, had a similarly designed 8-week, randomised, double-blind, placebo-controlled phase to evaluate the efficacy and safety of SEROQUEL monotherapy (fixed dose 300 mg or 600 mg daily) compared with placebo in adult patients with bipolar I or II disorder. The EMBOLDEN studies also included an active comparator arm, lithium in EMBOLDEN I and paroxetine in EMBOLDEN II.

The EMBOLDEN studies also included a 26- to 52-week continuation phase, where patients who achieved remission continued on the same dose of SEROQUEL or were switched to placebo. In the combined analysis of this phase, both doses of SEROQUEL significantly increased the time to recurrence of any mood event (hazard ratio 0.59 [95% CI, 0.41-0.84; P=0.004] for 300 mg/day and 0.45 [95% CI, 0.30-0.67; P<0.001] for 600 mg/day). In the subpopulation of patients with bipolar II disorder, both doses of SEROQUEL significantly reduced the risk of recurrence of any mood event compared with placebo (hazard ratio 0.47 [95% CI, 0.25-0.92; P<0.05] for 300 mg/day and 0.18 [95% CI, 0.07-0.51; P<0.001] for 600 mg/day).

The combined data indicate that SEROQUEL was generally well-tolerated and adverse events were consistent with the known safety profile of quetiapine. The most common adverse events in patients with bipolar disorder were dry mouth, somnolence, sedation, and dizziness. In the subpopulation of patients with bipolar II disorder, the most common adverse events were dry mouth, somnolence, sedation, dizziness, and headache. In the continuation phase of the EMBOLDEN studies, the most common treatment-emergent adverse events with SEROQUEL were headache, somnolence, nasopharyngitis, nausea, diarrhoea, and dry mouth and in the subpopulation of patients with bipolar II disorder were headache, dry mouth, somnolence, nasopharyngitis, dizziness, and nausea.

Similar findings have been observed for SEROQUEL XR, which was approved in the U.S. and Europe in 2008 for the acute treatment of depressive episodes associated with bipolar disorder. In an 8-week study (D144CC00002), SEROQUEL XR 300 mg/day demonstrated significant improvements in MADRS total scores from week 1 though week 8 (both P<0.001) compared with placebo.3

The mechanism of action of SEROQUEL, which involves both antipsychotic and antidepressant activities, may help explain its unique efficacy across the spectrum of mood episodes associated with bipolar disorder. The efficacy of quetiapine in depressive episodes may be partly explained by norepinephrine reuptake inhibition by norquetiapine, the active metabolite of quetiapine.

About SEROQUEL and SEROQUEL XR

Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 22 million patients worldwide. SEROQUEL has been approved in 94 countries for schizophrenia, 92 countries for bipolar mania, in 41 countries for bipolar depression and in 6 countries for bipolar maintenance.

SEROQUEL XR has been approved in 53 countries for schizophrenia, 19 countries for bipolar mania, in 20 countries for bipolar depression, in 9 markets for bipolar maintenance, in 1 market for Major Depressive Disorder (MDD), and in 1 market for Generalised Anxiety Disorder (GAD).

References

1. Calabrese JR, et al. The efficacy of quetiapine monotherapy in bipolar depression: combined data from the BOLDER and EMBOLDEN studies. Presented at the American Psychiatric Association, San Francisco, CA, USA, 16-21 May, 2009.

2. Young AH, et al. The efficacy of quetiapine monotherapy in bipolar II depression: combined data from the BOLDER and EMBOLDEN studies. Presented at the American Psychiatric Association, San Francisco, CA, USA, 16-21 May, 2009.

3. Suppes T, et al. Effectiveness of the new extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression (trial D144CC00002). Presented at the Eighth International Review of Bipolar Disorder Conference, Copenhagen, Denmark, 14-16 April, 2008.

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A childhood history of attention deficit/hyperactivity disorder (ADHD) has a significant impact on the course of bipolar disorder, regardless of whether ADHD symptoms persist in to adulthood, researchers have found.

“Cross-sectional studies suggest that up to 85% of prepubertal children with bipolar disorder also meet the criteria for ADHD, and, conversely, that up to 22% of children with ADHD also meet the criteria for bipolar disorder,” explain Mikael Landen (Karolinska Institute, Stockholm, Sweden) and team.

However, less is known about the prevalence of comorbid ADHD in adults with bipolar disorder and whether such symptoms influence the clinical course of the mood disorder.

“The question whether childhood ADHD has the same impact on bipolar disorder regardless of whether the ADHD symptoms remain in adulthood or not is critical, because it opens up the possibility that a mere history of childhood ADHD symptoms defines an etiologically distinct, early-onset bipolar sub-phenotype,” they add. 

To investigate, the researchers studied 60 men and 99 women with bipolar disorder who were aged an average of 39 years.

The participants underwent comprehensive evaluations to assess affective symptoms, childhood ADHD, and current ADHD symptoms. An interview with a parent was also conducted to obtain objective information about a history of childhood ADHD.

Overall, 114 (71.7%) patients had “pure” bipolar disorder without childhood or adulthood ADHD symptoms, 19 (12.0%) had a history of childhood ADHD without symptoms in adulthood, and 26 (16.4%) met criteria for ADHD in both childhood and adulthood.

Analysis revealed that the presence of either childhood only ADHD or childhood plus adult ADHD had a similar impact on the clinical course of bipolar disorder.

Patients with childhood only ADHD and those with childhood plus adult ADHD had a significantly earlier age at onset of their first psychotic symptom, at a combined average age of 14.2 years, than those with pure bipolar disorder, at an average age of 21.9 years.

Furthermore, both ADHD groups had a significantly earlier combined average age (16.7 years) at first affective episode than those with pure bipolar disorder (22.7 years).

The researchers also found that patients with childhood only and childhood plus adult ADHD experienced significantly more hypomanic, depressive mixed, and total affective episodes, and they more often had a history of interpersonal violence than those with pure bipolar disorder.

Landen et al conclude in the journal Acta Psychiatrica Scandinavica: “We found that childhood ADHD is common in bipolar patients and that a mere history of childhood ADHD irrespective of current ADHD is an important factor for the clinical course of bipolar disorder.”

They add: “A review of childhood ADHD symptoms in adult bipolar patients is warranted both clinically and in pathophysiological studies.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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Researchers in the UK have identified differences in brain activity and structure that may explain why some people at high risk for bipolar disorder remain mentally healthy while others develop the mood condition.

Speaking at a meeting of the Biochemical Society in London, lead researcher Sophia Frangou, from the Institute of Psychiatry in London, explained: “We know a lot about what makes people vulnerable to bipolar disorder, but most people who are at risk remain well.

“We wanted to find out what keeps them well.”

As up to 80% of the risk for developing bipolar disorder can be attributed to genetic factors, Frangou and team studied 227 members of 53 families affected by the mood condition.

Participants with and without bipolar disorder underwent brain imaging scans and performed cognitive tests designed to engage brain networks involved in emotional processing, decision-making, working memory, and attention.

The researchers found that genetic predisposition to bipolar disorder was associated with abnormalities in response inhibition in the amygdale, regardless of clinical phenotype.

They also found that disease expression was associated with increased emotional reactivity and reduced prefrontal modulation of limbic structures, while resilience was associated with preserved prefrontal function.

Although further research is needed to confirm the results, the findings are promising in terms of refining and individualizing risk indicators for mood disorders, said Frangou.

She concluded: “Being at risk of bipolar disorder does not mean that developing the illness is inescapable.

“We are closer now to identifying risk so that people can be better informed about life choices.

“Our research will help us personalize prevention and treatment strategies.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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UK researchers have found that depressive and social anxiety symptoms are more severe among tertiary care outpatients with anxiety disorders than among those with unipolar or bipolar depression.

However, the correlation between depressive and social anxiety symptoms in outpatients with anxiety disorders was neglible, the researchers note.

“These findings emphasize the need for comprehensive evaluation and treatment of secondary depression in patients with primary anxiety disorders,” say D Baldwin (University of Southampton) and co-authors.

For their study, the researchers included 75 patients (mean age 46 years) attending a tertiary referral mood and anxiety disorders service, of whom 15 were classified as having bipolar disorder, 35 had unipolar depression, and 19 had anxiety disorders. Depressive symptoms were assessed using the Montgomery??Ӂsberg Depression Rating Scale (MADRS) and social anxiety symptoms by the Liebowitz Social Anxiety Scale (LSAS).

Overall, patients had mean MADRS and LSAS scores of 20.1 and 63.4, respectively, corresponding to moderate intensity depression and anxiety. The authors also found a mean Clinical Global Impression of Severity (CGI-S) score of 3.5, corresponding to mild-to-moderate illness severity.

Patients with anxiety disorders had significantly higher LSAS (78.8 vs 50.0 and 59.4) and CGI-S (3.9 vs 3.1 and 3.3) scores than patients with bipolar or unipolar depression, respectively. LSAS and CGI-S scores were also significantly higher in patients with co-morbid diagnoses (n=37) than in patients with single diagnoses.

Baldwin et al further found a weak correlation between the severity of depressive and social anxiety symptoms in all patients, although both symptoms strongly correlated with overall illness severity.

Furthermore, the strongest correlation between MADRS and LSAS scores was seen in the bipolar group. This correlation was not seen in patients with anxiety disorders.

“The lack of correlation seen in the primary anxiety disorders group is probably explained by the broad range of diagnoses within that group, only 26% of whom had a primary diagnosis of social phobia,” write the authors in the Journal of Affective Disorders.

The team concludes: “Attempts should be made to clarify the determinants of greater social anxiety symptom severity in patients with more severe depressive symptoms.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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New data demonstrate that maintenance therapy with RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Treatment (RLAT) significantly delayed the time to relapse compared to placebo in patients with Bipolar I Disorder. Results of the study were presented this week at a major medical meeting.

Bipolar Disorder is a brain disorder that causes unusual shifts in a person’s mood, energy and ability to function. It is often characterized by debilitating mood swings from extreme highs (mania) to extreme lows (depression). Type I Bipolar Disorder is characterized based on the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the American adult population in any given year.

A randomized, double-blind, placebo-controlled, long-term study was conducted to evaluate the effect of RISPERDAL(R) CONSTA(R) as maintenance therapy in patients who met DSM-IV criteria for Bipolar I Disorder who were stable on medications or experiencing an acute manic or mixed episode. In the first phase of the study, 303 patients were stabilized on open-label RISPERDAL(R) CONSTA(R) for 26 weeks. In the double-blind phase, patients were randomized to either maintenance therapy with RISPERDAL(R) CONSTA(R) (N=154) or placebo (N=149). The median duration of treatment was nine months for patients in the RISPERDAL(R) CONSTA(R) group and five months for patients in the placebo group. The primary endpoint was time to relapse of any mood episode (depression, mania, or mixed).

Time to relapse was significantly longer in patients receiving RISPERDAL(R) CONSTA(R) monotherapy as compared to placebo (p<0.001). In addition, the rate of relapse during the double-blind treatment phase was lower among patients in the RISPERDAL(R) CONSTA(R) group (30 percent; 42/140) compared with the placebo group (56 percent; 76/135). The median dose of RISPERDAL(R) CONSTA(R) was 25 mg.

The most common adverse reactions in clinical trials in patients with bipolar disorder were weight increase (5% in monotherapy trial) and tremor and parkinsonism (greater than or equal to 10% in adjunctive therapy).

“This is the first randomized controlled study to demonstrate the efficacy of RLAT as a maintenance therapy in patients with Bipolar Disorder,” said Joseph Palumbo, M.D., Franchise Medical Leader, Psychiatry, Central Nervous System and Pain Therapeutic Area, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD). “These findings are important because the clinical course of Bipolar Disorder is often unpredictable and relapses can be very debilitating.”

The study was presented and sponsored by Janssen, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc and J&JPRD.

About RISPERDAL(R) CONSTA(R) Long Acting Treatment

RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Treatment (RLAT) is a long-acting injectable atypical antipsychotic therapy used for the treatment of schizophrenia and the maintenance treatment of Bipolar I Disorder. It was developed utilizing Alkermes’ proprietary Medisorb(R) drug-delivery technology. Using this technology, risperidone is encapsulated in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and administered to patients by intramuscular injection once every two weeks. RISPERDAL(R) CONSTA(R) is manufactured by Alkermes, Inc. and marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. and Janssen-Cilag outside of the U.S.

About Janssen

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. It currently has prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder.

About J&JPRD

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide.

IMPORTANT SAFETY INFORMATION FOR CONSUMERS ABOUT RISPERDAL(R) CONSTA(R)

Elderly Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL(R) CONSTA(R) (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL(R) CONSTA(R) and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL(R) CONSTA(R) and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

High blood sugar and diabetes have been reported with RISPERDAL(R) CONSTA(R) and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with RISPERDAL(R) CONSTA(R). Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.

RISPERDAL(R) CONSTA(R) and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.

Some people taking RISPERDAL(R) CONSTA(R) may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect can be reduced or it may go away over time.

Problems with the blood have been reported with RISPERDAL(R) CONSTA(R) and similar medications. Depending upon condition your doctor may choose to monitor your blood as you start therapy with RISPERDAL(R) CONSTA.

RISPERDAL(R) CONSTA(R) may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

RISPERDAL(R) CONSTA(R) should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

Painful, long lasting erections have been reported with the use of RISPERDAL(R) CONSTA(R). Call your doctor immediately if you think you are having this problem.

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL(R) CONSTA(R). Caution should be exercised when administering RISPERDAL(R) CONSTA(R) to a nursing woman.

RISPERDAL(R) CONSTA(R) may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

Some medications interact with RISPERDAL(R) CONSTA(R). Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while on RISPERDAL(R) CONSTA(R).

In a study of people taking RISPERDAL(R) CONSTA(R), the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.

In a study of people taking RISPERDAL CONSTA, the most common side effects in the treatment of Bipolar I Disorder were weight gain (when used alone) and tremors (when used with other medications).

If you have any questions about RISPERDAL(R) CONSTA(R) or your therapy, talk with your doctor.

IMPORTANT SAFETY INFORMATION FOR PROFESSIONALS ABOUT RISPERDAL(R) CONSTA(R)

WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. RISPERDAL(R) CONSTA(R) (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

Cerebrovascular Adverse Events (CAEs): CAEs, including fatalities, have been reported in elderly patients with dementia-related psychosis taking oral risperidone in clinical trials. The incidence of CAEs with risperidone was significantly higher than with placebo. RISPERDAL(R) CONSTA(R) is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including RISPERDAL(R) CONSTA(R). Clinical manifestations include muscle rigidity, fever, altered mental status and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.

Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose. Elderly patients appeared to be at increased risk for TD. Prescribing should be consistent with the need to minimize the risk of TD. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Hyperglycemia and Diabetes: Hyperglycemia, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics (APS), including RISPERDAL(R) CONSTA(R). Patients starting treatment with APS who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, RISPERDAL(R) CONSTA(R) elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.

Orthostatic Hypotension: RISPERDAL(R) CONSTA(R) may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be considered in patients for whom this may be of concern. RISPERDAL(R) CONSTA(R) should be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension.

Potential for Cognitive and Motor Impairment: RISPERDAL(R) CONSTA(R) has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that RISPERDAL(R) CONSTA(R) does not affect them adversely.

Seizures: RISPERDAL(R) CONSTA(R) should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold.

Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia.

Priapism has been reported. Severe priapism may require surgical intervention.

Thrombotic Thrombocytopenic Purpura (TTP) has been reported.

Administration: Care should be taken to avoid inadvertent injection into a blood vessel.

Suicide: The possibility of suicide attempt is inherent in psychotic illnesses. Close supervision of high-risk patients should accompany drug therapy.

Increased sensitivity in patients with Parkinson’s disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS.

Use Risperdal Consta with caution in patients with conditions and medical conditions that could affect metabolism or hemodynamic responses. (e.g. Recent Myocardial infarction or unstable cardiac disease)

Extrapyramidal Symptoms (EPS): The overall incidence of EPS-related adverse events in patients treated with 25 mg and 50 mg of RISPERDAL(R) CONSTA(R) and placebo, respectively, were akathisia* (4%, 11%, 6%), Parkinsonism+ (8%, 15%, 9%) and tremor (0%, 3%, 0%).

– Akathisia and restlessness

– Extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia

Weight Gain: In a 12-week trial, the percentage of patients experiencing weight gain (>7% of baseline body weight) was 6% placebo versus 9% RISPERDAL(R) CONSTA(R).

Maintenance Treatment: Patients should be periodically reassessed to determine the need for continued treatment.

Commonly Observed Adverse Reactions for RISPERDAL(R) CONSTA(R): The most common adverse reactions in clinical trials in patients with schizophrenia (greater than or equal to 5%) were headache, Parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth.

The most common adverse reactions in clinical trials in patients with bipolar disorder trials were weight increase (5% in monotherapy trial) and tremor and parkinsonism (greater than or equal to 10% in adjunctive therapy trial).

Source: Janssen

View drug information on Risperdal Oral Formulation.

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In her 1984 boot camp graduation photo, Adrienne Fitts is smiling. Her hair is neatly groomed, her Navy cap and dress whites are spotless and she is regulation fit and trim.

Flash forward to 2001. Fitts, now a retired Gulf War veteran, struggles with a mental illness called schizoaffective disorder. She is 90 pounds heavier and has developed type 2 diabetes. She is certain her regimen of antipsychotic drugs (”there are so many”) caused the diabetes as well as high blood pressure.

In April 2006, Adrienne Fitts suffers a stroke.

And there’s Gloria, a 56-year-old legislative advocacy worker, who also deals with both a major mental and medical condition. Gloria,has long-term clinical depression, neurological problems and on top of that, partial kidney failure.

“Multiple conditions are not rare and they become even more common as people get older,” says Dennis Freeman, Ph.D., the CEO of Cherokee Health Systems in Tennessee.

“Twenty-five percent of people in a primary care practice have a psychiatric illness,” says Wayne Katon, M.D., vice chair of the department of psychiatry and behavioral science at the University of Washington School of Medicine.

Children are vulnerable, too. “Kids with anxiety and depressive disorder,” Katon says. “This makes more of an impact on school performance and the ability to make and keep friends. Parents and schools have to be especially watchful for the additive effects of having two conditions.”

For many people, physical conditions can contribute to problems with their mental health problems that are often ignored and untreated. But your emotional health and physical health affect each other. Here’s what you should know.

The stakes are high.

When recovering from a heart attack, it’s natural to be focused on your physical recovery rather than your state of mind, but the two are intertwined, says Eric Goplerud, Ph.D.

“A heart attack produces large amounts of cortisol that precipitates depression,” explains Goplerud, the director of the Center for Integrated Behavioral Health Policy at George Washington University Medical Center.

“At least twenty percent with heart attacks have severe depression and these people are three times more likely to die if the depression is not dealt with promptly,” he says.

“People who have mental problems often have other health problems and they come together in legion,” Goplerud says.

Drugs that help your mind can harm your body.

In a health care Catch-22, the same drugs that help people manage bipolar disorder, schizophrenia and depression can have serious physical side effects.

As part of her treatment, Fitts has received some heavy-duty drugs, including olanzapine.

“Clozapine and olanzapine are the two antipsychotic drugs that the American Diabetes Association found the highest risk of causing weight gain and poor lipid control.” Goplerud says. As for drugs to combat depression, “some SSRIs are associated with weight gain and may contribute to diabetes. So you may be developing life-threatening illnesses from appropriate treatment of your mental illness.”

The dilemma works both ways, Goplerud adds: “Sometimes treatment we prescribe for in medical care end up causing mental health problems.” For instance, “People who have been legitimately prescribed powerful pain meds can become addicted.”

If you are ever prescribed antidepressants, or given medication to help you sleep, doses often need to be fine-tuned and you might need to try several drugs before to find one that works for you. Although primary care practitioners or clinic doctors can prescribe these drugs, follow-up can fall through the cracks. Let someone know if your treatment isn’t helping.

Patients have options, Goplerud says. “Talk to your physician about other medicines that might be used.”

Speaking up is vital to your mental health.

Fear of the stigma of mental illness can keep patients from speaking up, says Chris Koyanagi, policy director of the Bazelon Center for Mental Health Law. Some “are reluctant to tell primary care doctors about their psychiatric medicines: ‘I just don’t want my regular doctor to know.’”

Recalls Gloria: “As a teenager I had aches and pains and my parents took me to the Mayo clinic. They wanted me to see a psychiatrist. My father said fine, as long as they could come with me. The psychiatrist asked, ‘Are you depressed?’ Dad answered, ‘No, she’s not.’”

Meanwhile, physical conditions arose that could not be brushed aside. It was only years later, when she had an emotional collapse on the job that Gloria began treatment for depression.

Your health care is usually scattered across different settings.

“Health systems are fragmented, people are integrated,” says Dennis Freeman, Ph.D., the CEO of Cherokee Health Systems in Tennessee.

People are often are forced to work with an array of health care providers. “It’s daunting to go to three different clinics; it’s hard for anyone,” Katon says. “Fragmentation is even worse for people with mental health issues.”

Dangerous drug interactions are possible when no single health professional has a handle on all the medications you take: you could receive heart pills from one doctor and an antidepressant from another doctor without either being aware of what the other prescribes.

“At the least, one single person or entity needs to know all the medications you take and all the diagnoses you have,” Koyanagi says. “This can be your primary care physician, your mental health practitioner, your pharmacist.”

Some mental health care is “nested” with medical care.

Katon, who brings his psychiatric expertise to a medical practice one day a week, says, “It’s ideal if psychiatric care can be merged into medical care,”
“We found that mental health care programs with primary care onsite sometimes provided by a nurse practitioner or physician assistant who can do regular and effective screens, can link people to community services [work best],” Koyanagi agrees.

Federally qualified health centers, like Freeman’s Cherokee Health System in Tennessee, provide a full range of services from professionals who communicate daily with one another and have access to a single, unified medical record for each patient.

Unfortunately, it can be hard to find mental health care at all, much less integrated medical-mental care. “Half of counties in the United States don’t have mental health providers,” Freeman says.

In those areas, “You probably go to a primary care physician. They will do the very best they can. They’re not psychotherapists or behaviorists, but psychiatrists are in short supply every place, even among insured,” he says. “So you go to see your primary care physician, talk to your minister, if you’re in school it may be your teacher and guidance counselor.”

We’re all vulnerable at various times in our lives.

Just as we have ups and downs of physical health, everyone also deals with challenges that affect our moods and stability. It helps to know your baseline: What’s your usual mental state? How do you know when things are out of control?

“We all have times we’re not as resilient and not managing as well,” Freeman says. “That’s when the team needs to support you, help you through the rough times.”

You might need additional support, not only from mental health professionals but also the people in your life. Sharing confidences and concerns with trusted friends and family or joining a support group can help restore your mental balance.

Fitts has found and given support through the Depression and Bipolar Support Alliance, a peer group for people with mood disorders. Earlier, when she developed substance abuse issues which often go along with mental illness and can complicate medical treatment she looked outside herself for help. “I just made some decisions. It’s a process. I use a 12-step approach. I have a group in my church. It’s helped me to get my thoughts together.”

If you’ve been diagnosed with a medical illness and you don’t feel right emotionally: “Talk to your physician, tell your nurse.” Goplerud says. “Misery is not necessary. You don’t have to live with feeling physically miserable or mentally miserable.”

Source: Health Behavior News Service

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