title: Patterns of response to aripiprazole, lithium, haloperidol, and placebo across factor scores of mania.
abstract: BACKGROUND
  A previous factor analysis of Young Mania Rating Scale and Montgomery-Åsberg Depression Rating Scale items identified composite factors of depression, mania, sleep disturbance, judgment/impulsivity, and irritability/hostility as major components of psychiatric symptoms in acute mania or mixed episodes in a series of trials of antipsychotics. However, it is unknown whether these factors predict treatment outcome.
  
  
  METHODS
  Data from six double-blind, randomized, controlled clinical trials with aripiprazole in acute manic or mixed episodes in adults with bipolar I disorder were pooled for this analysis and the previously identified factors were examined for their value in predicting treatment outcome. Treatment efficacy was assessed for aripiprazole (n = 1,001), haloperidol (n = 324), lithium (n = 155), and placebo (n = 694) at baseline, days 4, 7, and 10, and then weekly to study end. Mean change in factor scores from baseline to week 3 was assessed by receiver operating characteristics curves for percentage factor change at day 4 and week 1.
  
  
  RESULTS
  Subjects receiving aripiprazole, haloperidol, and lithium significantly improved mania factor scores versus placebo. Factors most predictive of endpoint efficacy for aripiprazole were judgment/impulsivity at day 4 and mania at week 1. Optimal factor score improvement for outcome prediction was approximately 40% to 50%. Early efficacy predicted treatment outcome across all factors; however, response at week 1 was a better predictor than response at day 4.
  
  
  CONCLUSIONS
  This analysis confirms clinical benefits in early treatment/assessment for subjects with bipolar mania and suggests that certain symptom factors in mixed or manic episodes may be most predictive of treatment response.
authors.affiliation: VA Palo Alto Health Care System, 3801 Miranda Avenue, Mail Code 151 T, Building 4, 3rd Floor, Palo Alto, CA 94304 USA ; Stanford University School of Medicine, Stanford, CA USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Ostacher
authors.affiliation: VA Palo Alto Health Care System, 3801 Miranda Avenue, Mail Code 151 T, Building 4, 3rd Floor, Palo Alto, CA 94304 USA ; Stanford University School of Medicine, Stanford, CA USA.
authors.forename: Trisha
authors.initials: T
authors.lastname: Suppes
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd Suite E4.400, Houston, TX 77030 USA.
authors.forename: Alan C
authors.initials: AC
authors.lastname: Swann
authors.affiliation: Astrazeneca, 601 Office Center Drive Suite 200, Fort Washington, PA 19034 USA.
authors.forename: James M
authors.initials: JM
authors.lastname: Eudicone
authors.affiliation: Otsuka Pharmaceutical Europe Ltd., Gallions - 1st Floor Wexham Springs Framewood Road, London, Wexham SL3 6PJ UK.
authors.forename: Wally
authors.initials: W
authors.lastname: Landsberg
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ 08540 USA.
authors.forename: Ross A
authors.initials: RA
authors.lastname: Baker
authors.affiliation: Bristol-Myers Squibb, P.O. Box 5200, Princeton, NJ 08543-5200 USA.
authors.forename: Berit X
authors.initials: BX
authors.lastname: Carlson
keywords: Antipsychotic; Aripiprazole; Bipolar disorder; Factor analysis; Mania; Treatment outcome