Magazine article Clinical Psychiatry News

Aripiprazole in Bipolar Mania

Magazine article Clinical Psychiatry News

Aripiprazole in Bipolar Mania

Article excerpt

The Problem

You have a patient who has been diagnosed with bipolar I disorder. He has cycled into a severe manic episode with psychotic features.

The patient refuses treatment with typical mood stabilizers such as lithium, valproate, or carbamazepine. Because he has a physical and laboratory profile that is consistent with metabolic syndrome, you consider aripiprazole monotherapy that would target both manic and psychotic symptoms.

The Question

Is aripiprazole (Abilify) effective in the treatment of manic symptoms in bipolar disorder?

The Analysis

Our Medline search combined "aripiprazole" and "bipolar or mania."

The Evidence

Aripiprazole is a novel atypical antipsychotic with partial agonist activity at dopamine [D.sub.2] and serotonin 5-H[T.sub.1A] receptors and antagonist activity at serotonin 5-H[T.sub.2A] receptors.

The Food and Drug Administration cites two 3-week placebo-controlled trials supporting the efficacy of aripiprazole in the treatment of acute manic and mixed episodes associated with bipolar disorder, but our search revealed only one of them: Paul E. Keck Jr., M.D., and his associates compared the efficacy of aripiprazole and placebo in a double-blind study (Am. J. Psychiatry 2003;160:1651-8).

In this multicenter (38 sites) trial, 262 patients with bipolar I disorder were assigned to receive 30 mg of aripiprazole per day (or 15 mg/ day if needed for tolerability) or placebo. To enter the study, patients were required to have a Young Mania Rating Scale (YMRS) score of at least 20. (The YMRS has a maximal score of 60.) Exclusion criteria included serum concentrations at screening that were greater than 0.6 mmol/L of lithium or 50 mcg/mL of divalproex sodium (that is, therapeutic levels). Treatment efficacy was assessed primarily using the YMRS.

Concomitant medications were not allowed, with the exception of lorazepam (up to 6 mg/day on days 1-4, up to 4 mg/day on days 5-7, and up to 2 mg/day on days 8-10). No lorazepam was allowed beyond day 10. Anticholinergic treatment was limited to benztropine (up to 6 mg/ day).

After 3 weeks, the mean change in the YMRS was -3.4 in the placebo group and -8.2 in the aripiprazole group. …

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