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

Susan L. McElroy, Trisha Suppes, Mark A Frye, Lori L. Altshuler, Kevin Stanford, Brian Martens, Gabriele S. Leverich, Robert M. Post, Paul E. Keck

Research output: Contribution to journalArticle

42 Scopus citations


Background: 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 (≥ 50% reduction in MADRS total score), 11 (35%) patients met criteria for remission (final MADRS total score ≤ 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.

Original languageEnglish (US)
Pages (from-to)275-281
Number of pages7
JournalJournal of Affective Disorders
Issue number1-3
StatePublished - Aug 2007
Externally publishedYes



  • Akathisia
  • Aripiprazole
  • Bipolar
  • Depression

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Behavioral Neuroscience
  • Biological Psychiatry
  • Neurology
  • Psychology(all)

Cite this

McElroy, S. L., Suppes, T., Frye, M. A., Altshuler, L. L., Stanford, K., Martens, B., Leverich, G. S., Post, R. M., & Keck, P. E. (2007). Open-label aripiprazole in the treatment of acute bipolar depression: A prospective pilot trial. Journal of Affective Disorders, 101(1-3), 275-281.