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E-News from Washington Vol.04-13 May 7, 2004
One-drug Therapy Approach to Treating Bipolar Disorder

For the first time, researchers have demonstrated in separate short-term trials that a single drug therapy may be effective in treating both the manic and depressive phases of bipolar disorder. The condition (bipolar I and II) affects approximately 8 million Americans, who have relied on a combination of drugs to managed their symptoms, and who remain at high risk of committing suicide because of the difficulty in treating the disorder. 

Joseph R. Calabrese, M.D., made the announcement on May 5, 2004, at the annual meeting of the American Psychiatric Association (APA) in New York City. Calabrese, who studied the antipsychotic Seroquel, is the principal investigator and director of the National Institute of Mental Health (NIMH) Bipolar Research Center at University Hospitals of Cleveland and Case Western Reserve University School of Medicine. Dr. Calabrese led the randomized trial of 542 patients with bipolar disorder at 39 sites in the United States.

Seroquel is currently approved for the short-term treatment of acute manic episodes in bipolar 1 disorder and the treatment of schizophrenia. This is the first study of Seroquel in patients with both bipolar 1 (defined as one fully manic episode with periods of major depression) and bipolar II (defined as periods of hypomania, or high levels of energy and impulsiveness alternating with episodes of major depression), in which researchers specifically studied the drugs impact on the depressive phase of the illness. Typically, antipsychotic medications are not used as specific treatments for bipolar disorder.

In a statement, Dr. Calabrese said, “Though we will soon undertake an even larger trial, these preliminary findings should shape the standard of care for bipolar disorder going forward.” The center he co-directs in Cleveland with pediatric psychiatrist Robert Findling, M.D., is the first NIMH-funded center exclusively dedicated to the development of new treatments for bipolar disorder. “There was a dramatic response within eight days of beginning treatment in patients who were symptomatic with bipolar depression,” said Dr. Calebrese. “About 50% of patients responded quickly to treatment with Seroquel versus placebo, achieving remission from their symptoms, with the response lasting through the eighth and last week of the trial. Seroquel was also twice as effective as placebo in decreasing suicidal thoughts as a symptom of depression.

The trial tested two-dose levels of Seroquel (quetiapine fumarate), 300 or 600 mg per day, versus placebo. Of the 539 patients enrolled, 358 had bipolar disorder I and 181 had bipolar II. Common side effects included dry mouth, sedation, sleepiness, and dizziness. The research was supported by AstraZeneca Pharmaceuticals, which makes the drug Seroquel.

Beth Powell
Director, Public Policy and Professional Issues
American Mental Health Counselors Association
801 N. Fairfax Street, Suite 304
Alexandria, Virginia 22314
Phone: 800-326-2642, ext. 105
Phone: 703-548-6002, ext. 105
Fax: 703-548-4775
Website: www.amhca.org