A prospective, open-label study of Aripiprazole mono- and adjunctive treatment in acute bipolar depression.
OBJECTIVE
To examine the efficacy and tolerability of aripiprazole treatment for acute bipolar depression.


METHODS
A six-week prospective, nonrandomized, open label study was conducted in depressed bipolar outpatients (types I, II, and NOS), as diagnosed by DSM-IV criteria. Previous treatments were continued unchanged, and new treatments not permitted, except lorazepam up to 2 mg daily. Aripiprazole was dosed flexibly up to a maximum of 30 mg daily, based on tolerability and efficacy. Montgomery-Asberg Depression Rating Scale (MADRS) and Mania Rating Scale (MRS) scores were used to assess changes in mood symptoms. Side effect outcomes were measured. Data was analyzed using last observation carried forward methodology and Analysis of Variance.


RESULTS
Twenty patients (15 men, 5 women) with bipolar disorder (10 type I, 7 type II, 3 type NOS) enrolled in the study. Mean endpoint dose was 13.6 mg/d+/-10.0 mg/d. Thirteen (65%) patients completed 6 weeks of treatment. MADRS and MRS scores significantly improved during treatment. 44% of patients who completed at least one week of treatment were considered responders, based on > or =50% decrease in MADRS scores from baseline. Side effect measures were mostly unchanged during treatment.


CONCLUSIONS
Depressive symptoms improved in bipolar patients treated with open-label aripiprazole.
Dunn
Robert T
RT
Psychopharmacology Research Program, Cambridge Health Alliance, Cambridge, MA, USA. rdunn@challiance.org
Stan
Vanessa A
VA
Chriki
Lyvia S
LS
Filkowski
Megan M
MM
Ghaemi
S Nassir
SN
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D017109:Akathisia, Drug-Induced / Q000209:etiology; D000553:Ambulatory Care; D000928:Antidepressive Agents / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008140:Lorazepam / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole; D008140:Lorazepam