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Title: Aripiprazole, Ziprasidone Beneficial and Well Tolerated as Adjuncts in Bipolar I and II

"Aripiprazole, Ziprasidone Beneficial and Well Tolerated as Adjuncts in Bipolar I and II"

By Paula Moyer ATLANTA, GA -- June 2, 2005 -- Both aripiprazole and ziprasidone are effective and well tolerated as adjuncts to conventional mood stabilizers in the treatment of depression in bipolar I and bipolar II disorder, according to researchers. These findings, which were presented here May 24[^th at the 158^th American Psychiatric Association Annual Meeting (APA), will help psychiatrists as they struggle to avoid the trade-off of mood stabilization and treatment-associated adverse metabolic effects, the investigators reported. The results show "the usefulness of aripiprazole and ziprasidone in bipolar disorder as adjunct to reduce depressive symptoms," according to principle investigator Yahya Siddiqui, MD. In this 4-month study, the investigators saw no significant weight gain, a key adverse effect with other atypical antipsychotics. Dr. Siddiqui is professor of psychiatry and forensics at Sri Siddhartha Medical College in Tumkur, India.

The investigative team conducted an open label study that recruited 112 patients with either bipolar I or bipolar II disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV). The patients could be in any phase of the illness.

All of the patients received either aripiprazole or ziprasidone as adjunctive therapy, with treatment given in open-label fashion. The investigators assessed response of depressive symptoms with the Hamilton Depression Rating Scale version 17 (HDRS-17). The study design defined response was defined as a significant change from baseline to endpoint in the total mean HDRS-17 score.

The investigators also used the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions Scale (CGI) to assess response to treatment. To assess the tolerability of treatment, they used the Abnormal Involuntary Movement Scale (AIMS) to detect treatment-emergent dyskinesia and recorded patients' body mass index (BMI) at each visit to detect changes in weight that could be treatment-related. The follow-up consisted of visits with participating psychiatrists every two weeks for four months.

During the study period, 50 subjects received aripiprazole and 62 received ziprasidone; the study drugs were given as adjunctive therapies to either lithium or divalproex, which were used as foundational mood stabilizers. The mean dosage for ziprasidone was 120 mg daily; for aripiprazole, the average dose was 12 mg daily.

For all patients, the total average HDRS-17 scores significantly decreased from baseline to endpoint (P = .001). In the ziprasidone group, the average HDRS-17 total scores were reduced from 18 (standard deviation [SD] =3.2) to 8 (SD= 1.5) by 4 months in the aripiprazole-treated group and from 18 (SD=1.9) to 5 (SD=2.0) in the ziprasidone-treated group.

Patients tolerated both treatments well, the investigators reported. None developed the hallmark adverse effects that are associated with antipsychotics: none developed tardive dyskinesia or QTc prolongation, which have been linked to conventional antipsychotics, and no patients gained weight in a statistically significant manner during the four-month treatment period, an adverse effect often linked to atypical antipsychotics, the class in which both ziprasidone and aripiprazole are grouped.

These findings show that both aripiprazole and ziprasidone have potential as adjunctive therapy to address depressive symptoms in patients living with bipolar disorder, the investigators said. However, they urged replication of the data with double-blind, placebo-controlled trials.

[Presentation title: Aripiprazole and ziprasidone as adjunctive therapy for bipolar disorder. Abstract : NR420]

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