Bipolar disorder (BD) patients are twice as likely to suffer from post-traumatic stress disorder (PTSD) in the face of a traumatic event as the general population, suggest study results.

Study results also showed that PTSD in BD patients was associated with worse clinical outcome and increased illness severity, suggesting that “more attention should be drawn to comorbid PTSD in clinical care of BD patients,” according to Hans-Jorg Assion (Ruhr-University Bochum, Germany) and colleagues.

Using the Post-Traumatic Stress Diagnostic Scale (PDS) and the Clinician Administered PTSD Scale, the researchers assessed 74 BD I patients aged 48.3 years on average.

Overall, 50.0% of BD patients self-reported no trauma (BD??”), 29.7% had experienced traumatic events without a diagnosis of PTSD (BD+), and 20.3% had a definite diagnosis of PTSD (BD+P) according to the PDS. The 20.3% lifetime PTSD prevalence rate observed in this study is twice as high as that seen in the general population, say the researchers.

The researchers also found that the rate of lifetime exposure to at least one traumatic event was 50% in the cohort, which is similar to that seen in the general population.

“The discrepancy between the comparable expected rate of trauma exposure and higher prevalence rate of PTSD in patients with BD indicates a specific vulnerability of BD patients to trauma exposure,” writes the team in the journal Social Psychiatry and Psychiatric Epidemiology.

Furthermore, compared with BD??” and BD+ patients, BD+P patients had significantly higher scores on the Hamilton Depression Rating Scale (16.6 vs 7.7 and 9.6) and significantly lower scores on the Clinical Global Functioning scale (60 vs 72 and 68).

“These findings provide support for the argument that lifetime diagnosis of PTSD, but not reported trauma itself, worsens the clinical course of BD,” say the authors.

Patients with PTSD were also significantly more likely to have at least one alcoholic parent and to have suffered more severe physical violence by parents, parental disregard, and sexual assault by a family member or acquaintance compared with patients without PTSD.

Based on their findings, the researchers call for further studies focusing on protective psychosocial steps and psychotherapeutic strategies in the treatment of traumatic experiences and PTSD in BD.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2009

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Comorbid migraine and bipolar disorder (BD) appears to be underpinned by a genetic susceptibility locus on chromosome 4 and possibly another on chromosome 20, conclude US researchers.

While clinically heterogeneous, BD and migraine have a significant genetic component. Previous studies have identified overlapping regions of genetic linkage and two functional similar voltage-dependent calcium channels have been associated with both disorders.

To investigate further, Ketil Joachim Oedegaard, from the University of California, San Diego, and colleagues studied data from the National Institutes of Health Genetics Initiative for Bipolar Disorder. They identified 31 families with both migraine and bipolar disorder, yielding a total of 201 individuals, including 105 siblings with either broad or narrow phenotypes for both disorders.

The results, published in the Journal of Affective Disorders, indicate that there was a linkage signal at chromosome 4q24 for migraine, although not BD, at a logarithm of odds (LOD) score of 2.26, which the team notes has been significantly linked to migraine in two previous samples.

Furthermore, a locus on chromosome 20p11 was found to have overlapping association with both migraine and BD, at LOD scores of 1.95 and 1.67, respectively. Again, this region has been previously linked to BD and contains the potassium dependent sodium/calcium exchanger gene SLC24A3.

The team concludes: “The findings here suggest that information regarding a prevalent comorbid neurological disorder (ie, migraine) can provide an additional tool for stratifying a bipolar study sample.”

They add: “It is hoped that this approach will facilitate the detection of underlying mutation(s) elucidating the complex relation between migraine and BD, and that this approach will help unravel molecular pathways and the development of rational treatment strategies for both disorders.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2009

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The neurocognitive performance of bipolar disorder patients is unaffected by medication use, says a team of researchers in findings that suggest that neurocognitive deficits form a part of the disorder.

It has been established in previous studies that neurocognitive performance deficits persist even in euthymic bipolar disorder patients. However, the impact of medication on performance is unclear.

To investigate further, Utpal Goswami, from the University of Delhi in India, and colleagues administered a series of neuropsychologic tests, assessing executive function, memory, and attention, to 44 patients with bipolar I disorder, of whom 22 were drug-free.

The team reports in the journal Acta Psychiatrica Scandinavica that, over the range of neuropsychologic tasks, there were no significant differences between patients receiving medication and those who were drug-free.

There was a small trend for patients receiving medication to perseverate less on the five-point test and to have better delayed recall than drug-free patients, but these differences were eliminated when controlling for residual mood symptoms.

Residual depressive symptoms were shown to be significantly correlated with poor performance on auditory??”verbal memory items. Medicated patients had more severe illness than drug-free patients, but none of the differences on severity variables were significant.

“In this small study, medication, predominantly mood stabilizers, was found to have small to medium, but statistically insignificant, effect sizes on the neurocognitive test performance of euthymic bipolar disorder subjects when residual mood symptoms were controlled,” the team concludes.

In an accompanying editorial, Eduard Vieta, as invited guest editor, said: “The relative unimportance of medication on bipolar disorder-associated deficits indicates that one of the possible ways to treat and prevent the neurocognitive impact of recurrences could be early, intensive, continued pharmacologic treatment, addressed at tackling subthreshold depressive symptoms and the prevention of further episodes.

“Other potentially useful tools include psychoeducation and interventions aimed at reverting the cycle of allostatic load.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2009

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To help bring greater certainty to the measurement of medication levels in a patient’s bloodstream for three drugs with narrow therapeutic ranges, the U.S. Pharmacopeial Convention (USP) is releasing new certified reference materials (CRMs).

The three new CRMs are for carbamazepine, an anticonvulsant and mood stabilizing drug used primarily in the treatment of epilepsy and bipolar disorder; phenytoin, commonly used as an antiepileptic; and theophylline, used in the treatment of respiratory diseases. These three drugs are among a group of medicines that are often monitored in the bloodstream of patients that have been prescribed the drugs. Such medicines may need to be carefully monitored for a number of reasons, including a narrow therapeutic range or risk of toxicity. Therapeutic drug monitoring may also be necessary for drugs that are intended to maintain the absence (as opposed to the presence) of a medical condition, such as seizures.

CRMs represent an important step forward for USP reference standards, which are the physical materials used to demonstrate compliance to written USP standards designating a medicine and its ingredients’ identity, quality, purity, strength and consistency. CRMs are reference standards accompanied by a certificate of analysis. A CRM is rigorously tested for one or more chemical or physical properties (such as purity). A property value with associated uncertainties certified to be true based on these tests is assigned to the CRM after a thorough statistical treatment of the data. The path of metrological traceability, which provides information on how the measurement was made and which standards were used to support the measurement, is included in the Certificate of Analysis, as well as the estimated level of uncertainty associated with the assigned value. This added information regarding uncertainties and traceability is provided for users of the reference materials. Procedures for determining compliance with USP compendial quality standards remain unchanged since, as stated on the Certificates of Analysis, the associated uncertainties are not used as part of the calculation value for quantitative USP-NF applications.

The new CRMs will be used by the in vitro diagnostic device industry, which manufactures medical devices that examine specimens derived from the human body (e.g., blood or tissue donations) to provide information related to a physiological or pathological state or to monitor therapeutic measures. Requirements in Europe state that all measurements should be traceable to standards of a “higher metrological order,” that is, more certain measurements. The International Organization for Standardization (ISO) states that, where possible, such standards should be CRMs. USP is the first global pharmacopeia to be ISO-certified as a producer of chemical CRMs.

“In releasing these three new CRMs, USP is meeting the needs of the multi-national in vitro diagnostic device industry,” said William Koch, Ph.D., USP’s chief metrology officer. “For these three products, a higher degree of certainty in measurement is extremely important. In Europe specifically, regulations support use of CRMs for in vitro diagnostic devices. However, this is useful for manufacturers of these medicines worldwide.”

Source: Francine Pierson

US Pharmacopeia

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There are limited differences between bipolar II disorder (BDII) depression and unipolar depression, say Australian scientists who suggest previously suggested differences can be explained by age, gender, and severity.

While previous studies comparing BD and depression have found that the former is characterized by a more severe mood state, lability of mood, and psychotic and atypical features, it is noteworthy that the majority of the studies have involved patients with bipolar I disorder.

To compare the depressive symptom profile of BDII patients with that of unipolar depression patients, Gordon Parker and colleagues from the University of New South Wales in Sydney studied 394 outpatients attending a specialist depression clinic. All participants were assessed using the Mood Assessment Program.

In all, 119 patients had BDII, 104 had melancholic unipolar depression, and 171 had non-melancholic unipolar depression. There were no significant differences between BDII and unipolar depression patients in gender distribution or state depression severity scores.

BDII patients were significantly younger than both unipolar depression and melancholic unipolar patients, at 38.5 versus 42.7 and 46.4 years, respectively, and non-melancholic unipolar patients were significantly younger than melancholic patients, at 40.5 years.

While BDII patients and unipolar patients showed minimal differences in symptom severity scores, BDII patients were more likely to report their thinking as slowed and feel less of a need to be close to people.

Interestingly, melancholic unipolar depression patients were more likely to report anticipatory and consummatory anhedonia, non-reactivity, psychomotor slowing and weight loss than non-melancholic patients.

BDII patients differed from melancholic unipolar patients only in terms of inability to derive pleasure from normal pleasurable activities and weight loss, and from non-melancholic patients in terms of feeling physically slowed, having slowed thinking, feeling paralysed, and having less of a need to be close to people. Different results were seen with prototypic symptom patterns, indicating the findings are affected by rating strategies and age.

“We conclude that our study found limited differentiation of bipolar II depression from unipolar, melancholic and non-melancholic depression, and that differences highlighted in the few previous reports may reflect age, gender and severity differences,” the team writes in the journal Acta Psychiatrica Scandinavica.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2009

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Polymorphisms in two genes related to the circadian rhythm may be associated with the development of pediatric bipolar disorder, although not with age at onset, US researchers have discovered.

Building on observations that, particularly in children, bipolar disorder is characterized by rapid cycling and switching of mood episodes, there has been interest in the role of circadian genes in the development of the disorder.

As retinoic acid receptor (RAR)-related orphan receptor alpha (RORA) and beta (RORB) genes have been linked to bipolar disorder in a mouse model, Alexander Niculescu, from Indiana University in Indianapolis, and colleagues studied 153 probands with childhood-onset bipolar I disorder and two affected parents, 152 independent, non-overlapping cases, and 140 healthy controls.

The participants, who had average ages of 17.5 years, 20.3 years, and 42.9 years, respectively, were genotyped for 322 single nucleotide polymorphisms (SNPs) in the RORA gene and 44 SNPs in the RORB gene.

Eighteen RORA SNPs and eight RORB SNPs in the family sample, and 13 RORA SNPs and 16 RORB SNPs in the case sample were significantly associated with bipolar disorder on initial analysis. However, no RORA SNPs and only four RORB SNPs survived Bonferroni correction: rs1157358, rs7022435, rs3750420, and rs3903529.

Interestingly, all of these SNPs were significant only in the case versus control sample and had odds ratios in the opposite direction in the family sample, giving overall odds ratios for bipolar disorder of 1.162, 1.150, 1.176, and 1.094, respectively.

Three haplotype blocks on RORB, indicating a further 11 SNPs, were linked to bipolar disorder in the case sample but not the family sample. No RORA or RORB SNPs were associated with bipolar age at onset.

The team writes in the journal BMC Psychiatry: “Our findings suggest that clock genes in general and RORB in particular may be important candidates for further investigation in the search for the molecular basis of bipolar disorder.

“These results are supported by our current understanding of the expression, localization, and possible role of RORB in the brain and are also consistent with data from animal models of bipolar disorder.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2009

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There is no gradient in affective temperament scores from bipolar I disorder through unipolar depressive patients to healthy individuals, say UK researchers who found high dysthymic scores in both patient groups.

The concept that certain affective temperaments may represent endophenotypic manifestations of bipolar spectrum disorder vulnerability has received increased interest in recent years. Alongside this, the boundaries of bipolarity have been expanded through the emerging concept of a clinically relevant broad “bipolar spectrum,” the researchers note.

To examine the notion that there is a gradient in affective temperament scores from bipolar I disorder, through bipolar II disorder and recurrent major depression disorder (MDD-R), to healthy controls, Arianna Di Florio, from University Hospital of Wales in Cardiff, and colleagues administered the Temperament Evaluation of Memphis, Pisa, Paris, and San Diego (TEMPS-A) to 927 individuals.

The participants consisted of 298 patients with bipolar I disorder, 108 bipolar II disorder patients (including 70 patients diagnosed with MDD-R who scored ?20 on the Hypomania Checklist [HCL-32]), 312 MDD-R patients who scored ?19 on the HCL-32, and 209 mentally healthy controls.

Bipolar II disorder patients scored highest on the cyclothymic, irritable, and dysthymic subscales of the TEMPS-A, with controls scoring lowest. On the hyperthymic subscale, bipolar II disorder patients and controls scored highest. There were no differences in median scores on the anxious subscale. However, significant differences across all four groups were found on all five subscales.

Logistic regression analysis indicated that only the dysthymic subscale distinguished between patients and controls, with all three groups differing significantly from controls. There were no significant differences among the patient groups when taking into account number of manic and depressive episodes and age at onset.

Interestingly, the anxious subscale was able to distinguish between MDD-R patients and controls, with no other associations identified, the team writes in the Journal of Affective Disorders.

They conclude: “These data suggest that dysthymic temperament may be a common intermediate phenotype in affective disorders.”

The researchers add: “We failed to find evidence to support the hypothesis that affective temperament scores show a gradient between bipolar I disorder, bipolar II disorder, MDD-R, and controls.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2009

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Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved bipolar disorder.

Bipolar disorder, which affects approximately 5.7 million adults in the United States, is a debilitating, chronic condition that requires lifelong treatment and management.1 More than 90 percent of patients with bipolar disorder have recurring mood episodes,2 making it important to establish a long-term treatment plan to help prevent recurrence and stabilize mood. The recurrence of mood episodes associated with bipolar disorder can have a devastating impact on patients’ lives, and the disease is associated with high rates of disability.3

“The FDA approval of Geodon provides an additional treatment option for patients with bipolar disorder, who require maintenance therapy to keep the symptoms of the disease under control,” said Charles Bowden, clinical professor of psychiatry and pharmacology, University of Texas Health Science Center.

The efficacy and safety of Geodon for the adjunctive maintenance treatment of bipolar disorder were studied in a six-month, double-blind, randomized, placebo-controlled trial in adult patients with bipolar I disorder. After an open-label stabilization period of 10 to 16 weeks, 240 patients were randomized to continue on Geodon plus lithium or valproate, or to have Geodon replaced by placebo.4 The primary endpoint in this study was time to recurrence of a mood episode requiring intervention.

The data demonstrated that Geodon plus lithium or valproate was superior to placebo plus lithium or valproate in increasing the time to recurrence of a mood episode. During six months of treatment, 19.7 percent of patients in the Geodon arm required intervention for a mood episode, compared with 32.4 percent of patients in the placebo arm.4

The adjunctive Geodon treatment regimen was generally well-tolerated.4 Discontinuation due to adverse events occurred in 13 percent of patients in the placebo group, compared with 9 percent of those in the Geodon group.5 The safety and tolerability data from this study are consistent with Geodon’s already well-established safety profile in adult patients.

“The recurrence of mood episodes associated with bipolar disorder can have a devastating impact on patients’ lives,” said Dr. Ilise Lombardo, senior medical director, Pfizer Specialty Care. “This approval underscores Pfizer’s commitment to supporting people suffering from serious mental health disorders.”

Geodon is also FDA-approved for the treatment of acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for the treatment of schizophrenia. Since the FDA approval of Geodon in February 2001, nearly 2 million adult patients have been treated with this important therapy.6

1 National Institute of Mental Health. Bipolar disorder. Available here. Accessed October 27, 2009.

2 Solomon DA, Keitner GI, Miller IW, Shea MT, Keller MB. Course of illness and maintenance treatments for patients with bipolar disorder. J Clin Psychiatry. 1995;56:5-13.

3 Sajatovic M. Bipolar disorder: disease burden. Am J Manag Care. 2005;11:S80-S84.

4 Vieta E, Bowden C, Ice KS, et al. A 6-month, randomized, placebo-controlled, double-blind trial of ziprasidone plus a mood stabilizer in subjects with bipolar I disorder. Poster presented at the 17th European Psychiatric Association European Congress of Psychiatry, January 25, 2009, Lisbon, Portugal.

5 Pfizer Inc. Clinical study report synopsis: Protocol A1281137. A phase 3, randomized, 6-month, double blind trial in subjects with bipolar I disorder to evaluate the continued safety and maintenance of effect of ziprasidone plus a mood stabilizer (vs placebo plus a mood stabilizer) following a minimum of 2 months of response to open-label treatment with both agents.

6 Data on file. Pfizer Inc.

Source
Pfizer Inc.

View drug information on Ziprasidone.

Once again, the National Bipolar Foundation and the MedicAlert Foundation receive a proclamation endorsing their “Safe ’til Stable” program, which is now being widely accepted as a preventive health care measure for bipolar disorder. Today, the National Bipolar Foundation received a proclamation of endorsement via Federal Express Priority Mail from the Lt. Governor of Louisiana Mitch Landrieu. The National Bipolar Foundation states that lawmakers and statesmen are jumping on board with this social movement. Last week, there was a proclamation and press conference held at the University of Tennessee Health Science Center, with documented experts standing united in support of the new “Safe ’til Stable” program. The keynote speaker at that press conference was Memphis Mayor A.C. Wharton. The day before, the National Bipolar Foundation received by express delivery a proclamation co-signed by the Speaker of the Senate, Ron Ramsey, and Senator Mark Norris of the Tennessee State Senate.

People living with bipolar disorder are being brought to the forefront of conversations across the country. The National Bipolar Foundation has board members in California, New York, Minnesota, Louisiana, Oregon, and Tennessee. It also has volunteers in 38 states. All these centers of influence are now focusing on the idea of reducing the stigma associated with bipolar disorder. The founder of the National Bipolar Foundation, Marc Kullman, states that the more the stigma is reduced, then the more people will come forward to seek help for the disorder. Kullman was quoted three weeks ago in the Boston Globe in defense of those living with bipolar disorder and dismissing the perceived correlation between bipolar disorder and criminal activity. His point was collaborated by several medical doctors. That same week on CBS News Radio, Marc Kullman was given another opportunity to explain that people living with bipolar disorder are no more a problem than any other group found in society as a whole. Kullman concluded by encouraging people to search for lists of people with bipolar disorder on the Internet. One will find an amazing array of people, and find out why, without question, bipolar disorder is called the disease of geniuses.

The National Bipolar Foundation has released this week a Public Service Announcement for television and issued it to over 3000 network affiliate stations across the country. The message of the commercial is, “we can talk about cancer, and other illnesses, so why should bipolar disorder be spoken about in a whisper?” As the holidays bring families together across the nation, the commercial is expected to receive tremendous air-time. As stated by Mayor A C Wharton in the press conference last week, “The holidays are a chance to reach out to that family member who doesn’t quite fit in, or is having a rough time while all the rest of the family bonds and enjoys the day.”

Dr Kennard Brown, Executive Vice-Chancellor and Chief of Staff at the University of Tennessee, Health Science Center, said that, “the National Bipolar Foundation and its new ‘Safe ’til Stable’ program was a great break-through for people living with bipolar.” Dr. Brown went on to say that the National Bipolar Foundation would receive all the support that the medical program could provide, and furthermore, that he would be remiss if he did not fully support and endorse this program. Dr. Brown is now leading a charge that challenges others to donate, and is in discussions with the foundation about possible research.

Brad Champlin, former Senior Vice-President of Region Bank Corp, and co-founder of the National Bipolar Foundation, has been quoted on many occasions as saying what a great asset bipolar people are to a company. If only we could harness their energy. Mr. Champlin does not have bipolar disorder, but has been an outspoken proponent of the foundation because he sees value in all people. In his community, he is a well-known businessman, and forward thinker among his peers. It is no surprise that Mr. Champlin wants to help reduce stigma, educate, and seek affordable health care for all people living with bipolar disorder.

The MedicAlert Foundation, a cooperative partner in the “Safe ’til Stable” program, sees this effort by both foundations as the next great step for their foundation. The cooperative venture has produced a preventative care program called “Safe ’til Stable.” It provides vital medical information to emergency responders in a time of need through our live 24-hour emergency response service. In a medical emergency, this can help reduce the trauma experienced by individuals impacted with bipolar disorder. If an individual experiences an event, first responders on the scene (e.g., law enforcement, emergency services personnel, etc.) will look for a medical ID with the “MEDIC ALERT” symbol. The Safe ’til Stable program is a milestone in that those with bipolar disorder will have a voice in times when they cannot speak for themselves, and will be properly routed in times of emergency, providing a sense of security for the individual and those close to them.

The National Bipolar Foundation (NBPF) was founded in 2007 by Marc Kullman in order to reduce stigma, educate, and seek affordable healthcare for those people living with bipolar disorder. A National Awareness Initiative has been launched to spread awareness through press releases, press conferences, proclamations, influential people, and an online campaign through social media networking. The MedicAlert Foundation, founded in 1956, is the leader in providing identification and emergency medical information. Together both foundations have developed a program that will prevent the misdirection, misdiagnosis, and mistreatments of participants, saving precious time and dollars.

Lawmakers at all levels see that bipolar disorder is everywhere and across all racial, ethnic, religious, and socio-economic barriers. It deserves the attention of all citizens to wipe away the stigma. The National Bipolar Foundation takes great note of the late Senator Ted Kennedy’s efforts in championing the cause of the mentally ill. This is clearly an area in which all Americans can join hands and help along. It has long been an issue that is supported on a bipartisan basis. It seems that the National Bipolar Foundation and its many supporters can stand in unison as Americans.

Source: National Bipolar Foundation

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