Capsules May Be
Effective in Treating Bipolar Disorder
Reformulation of Shire Pharmaceuticals' Carbatrol for
epilepsy
may work for Bipolar
Disorder with no clinically significant weight gain or increase in glucose
levels.
(November 18, 2004) -- University of North Carolina at Chapel Hill researchers have announced study
results finding that a formulation of three-beaded extended-release
carbamazepine capsules (ERC-CBZ) was effective, safe and tolerable in the
treatment of
bipolar I disorder and showed no clinically significant weight gain
or changes in blood glucose between treatment groups. The pooled data presented
by UNC researchers today (Nov. 18) at the 17th annual U.S. Psychiatric and
Mental Health Congress in San Diego are results from two of the first trials to
use an extended-release form of carbamazepine capsules (Carbatrol) manufactured by Shire
Pharmaceuticals.
"People affected by bipolar disorder experience intense highs and-or
irritability, which may be followed or paired with crippling lows. Bipolar
patients also may be affected by additional disorders including
anxiety
disorders,
attention deficit disorder and
substance abuse," said Dr. Richard H. Weisler, primary investigator of both clinical trials and adjunct professor of
psychiatry at UNC's School of Medicine.
"Many patients at present still either fail to respond or have trouble
tolerating
medications for their bipolar disorder. For this reason, finding a
treatment regimen that works effectively in both manic states and the large
number of mixed patients who are both seriously depressed and manic at the same
time is a very important addition to our treatment options for patients and
their doctors."
Weisler also is adjunct assistant professor of psychiatry and behavioral
sciences at Duke University Medical Center and has a private practice in
Raleigh.
More than 2 million American adults are estimated to have bipolar disorder in
any given year. In fact, recent research suggests approximately one in 30 adults
suffer from bipolar disorder. Bipolar disorder, also known as
manic-depressive
illness, is characterized by episodes of mania and depression while experiencing
periods of normal mood in between. Although bipolar disorder can have
devastating effects on an individual's life, it is often not recognized as an
illness and the majority of people may suffer for years before it is properly
diagnosed and treated.
"Proper diagnosis and earlier treatment can usually alter the course of the
illness," said Weisler.
This analysis of pooled data resulted from two identically designed,
three-week, double-blind, placebo-controlled phase 3 trials of ERC-CBZ
monotherapy in patients initially requiring hospitalization. The trial involved
443 patients ages 18 to 76 years with a Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition (DSM-IV) diagnosis of bipolar disorder (current
episode manic or mixed) who were randomized to double-blind treatment with
either ERC-CBZ or placebo.
Efficacy was assessed by Young Mania Rating Scale (YMRS), Clinical Global
Impression-Severity (CGI-S), Clinical Global Impression-Improvement (CGI-I), and
Hamilton Depression Rating Scale (HDRS). Safety and tolerability were assessed
by measurements of weight, blood glucose, cholesterol and interval between
heartbeats, as well as adverse event monitoring.
ERC-CBZ treatment was initiated at 200 milligrams twice daily and titrated,
as necessary, by 200 milligrams per day up to 1,600 milligrams per day. The
average final dose of ERC-CBZ was 700 milligrams per day, with many patients
receiving 400 to 600 milligrams at final daily dose.
Of the 443 patients, 240 (54.2 percent) completed the study. Treatment with
ERC-CBZ was associated with significant improvements in mean YMRS total scores
at all time points during the trial. At the end of the trial, significant
reductions in YMRS total scores were observed in both manic and mixed patients.
Furthermore, significant improvements were shown in CGI-I and CGI-S scores.
Total score improvements in HDRS were observed in ERC-CBZ treated mixed patients
at endpoint.
ERC-CBZ was generally well-tolerated in both manic and mixed bipolar
patients. The 240 patients in the final group demonstrated no clinically
significant weight gain, no significant changes in blood glucose and intervals
between heartbeats between treatment groups, and no serious rashes, blood
disorders or ECG adverse events. Treatment with ERC-CBZ caused a modest increase
in total cholesterol of 21.1 milligrams/deciliter of which about 20 percent was
the beneficial HDL cholesterol. Common treatment-emergent adverse events were
mild to moderate in nature and included dizziness, somnolence, nausea, vomiting
and loss of coordination. However, these events were transient and most occurred
during the first week of treatment.
Of patients recruited into the trial, 79 percent were from the United States
and 21 percent from India; and 58.5 percent were white, 14.8 percent black and
26.7 percent were other ethnicities. The mean age of patients was 37.5 years of
age, and 62 percent were male. Mixed presentation patients accounted for 34
percent and 62 percent of patients suffered from mania.
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