title: Open-label aripiprazole in the treatment of acute bipolar depression: a prospective pilot trial.
abstract: 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 (> 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Psychopharmacology Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio, United States. susan.mcelroy@uc.edu
authors.forename: Susan L
authors.initials: SL
authors.lastname: McElroy
authors.forename: Trisha
authors.initials: T
authors.lastname: Suppes
authors.forename: Mark A
authors.initials: MA
authors.lastname: Frye
authors.forename: Lori L
authors.initials: LL
authors.lastname: Altshuler
authors.forename: Kevin
authors.initials: K
authors.lastname: Stanford
authors.forename: Brian
authors.initials: B
authors.lastname: Martens
authors.forename: Gabriele S
authors.initials: GS
authors.lastname: Leverich
authors.forename: Robert M
authors.initials: RM
authors.lastname: Post
authors.forename: Paul E
authors.initials: PE
authors.lastname: Keck
mesh_terms: D000208:Acute Disease; D000328:Adult; D017109:Akathisia, Drug-Induced / Q000175:diagnosis; D000927:Anticonvulsants / Q000627:therapeutic use; D018692:Antimanic 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; D001835:Body Weight / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D010865:Pilot Projects; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000927:Anticonvulsants; D018692:Antimanic Agents; D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole