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Open-label aripiprazole in the treatment of acute bipolar depression: a prospective pilot trial.

AbstractBACKGROUND:
Increasing evidence indicates that some second-generation antipsychotics are efficacious in bipolar depression, but there are few data on this illness for the novel agent aripiprazole.
METHODS:
Aripiprazole response was prospectively assessed for 8 weeks with the Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impression Scale Modified for Bipolar Illness (CGI-BP), and the Young Mania Rating Scale (YMRS) in 31 bipolar patients with acute depression inadequately responsive to 1 mood stabilizer. Side effects and body weight were also evaluated. Outcome measures were analyzed with repeated measures ANOVAs.
RESULTS:
Patients showed a significant decrease in mean MADRS total and CGI-BP-Depression Severity scores, but only 14 (45%) completed the 8-week trial. Thirteen (42%) patients met criteria for response (> or =50% reduction in MADRS total score), 11 (35%) patients met criteria for remission (final MADRS total score < or =12), and 9 (29%) patients discontinued aripiprazole for side effects, most commonly akathisia (N=4). As a group, patients showed statistically insignificant weight gain (0.8+/-2.5 kg) over the 8-week trial.
CONCLUSION:
Aripiprazole was associated with beneficial effects on mood in some patients with bipolar depression, but also had a high discontinuation rate, primarily due to side effects. Double-blind, placebo-controlled studies are necessary to determine aripiprazole's efficacy, tolerability, and safety in bipolar depression.
AuthorsSusan L McElroy, Trisha Suppes, Mark A Frye, Lori L Altshuler, Kevin Stanford, Brian Martens, Gabriele S Leverich, Robert M Post, Paul E Keck Jr
JournalJournal of affective disorders (J Affect Disord) Vol. 101 Issue 1-3 Pg. 275-81 (Aug 2007) ISSN: 0165-0327 [Print] Netherlands
PMID17229469 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Anticonvulsants
  • Antimanic Agents
  • Antipsychotic Agents
  • Piperazines
  • Quinolones
  • Aripiprazole
Topics
  • Acute Disease
  • Adult
  • Akathisia, Drug-Induced (diagnosis)
  • Anticonvulsants (therapeutic use)
  • Antimanic Agents (therapeutic use)
  • Antipsychotic Agents (adverse effects, therapeutic use)
  • Aripiprazole
  • Bipolar Disorder (diagnosis, drug therapy, psychology)
  • Body Weight (drug effects)
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Dropouts
  • Pilot Projects
  • Piperazines (adverse effects, therapeutic use)
  • Prospective Studies
  • Psychiatric Status Rating Scales
  • Quinolones (adverse effects, therapeutic use)

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