Randomised, double-blind, placebo-controlled study of olanzapine in patients with bipolar I depression.
BACKGROUND
Atypical antipsychotics are widely used in bipolar mania. However, the efficacy of atypical antipsychotics in bipolar depression has not been comprehensively explored.


OBJECTIVE
To evaluate olanzapine monotherapy in patients with bipolar depression.


METHODS
Patients with bipolar depression received olanzapine (5-20 mg/day, n = 343) or placebo (n = 171) for 6 weeks. The primary outcome was change from baseline to end-point in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Secondary outcomes included: Clinical Global Impression - Bipolar Version (CGI-BP) scale, 17-item Hamilton Rating Scale for Depression (HRSD-17) and Young Mania Rating Scale (YMRS) scores, and the rate of response (≥50% reduction in MADRS at end-point), recovery (MADRS ≤12 for ≥4 weeks plus treatment completion) and remission (MADRS ≤8). The trial was registered with ClinicalTrials.gov (NCT00510146).


RESULTS
Olanzapine demonstrated: significantly greater (P<0.04) improvements on MADRS (least-squares mean change -13.82 v. -11.67), HRSD-17 and YMRS total scores and all CGI-BP subscale scores v. placebo; significantly (P≤0.05) more response and remission, but not recovery; significantly (P<0.01) greater mean increases in weight, fasting cholesterol and triglycerides; and significantly more (P<0.001) patients gained ≥7% body weight.


CONCLUSIONS
Olanzapine monotherapy appears to be efficacious in bipolar depression. Additional long-term studies are warranted to confirm these results. Safety findings were consistent with the known safety profile of olanzapine.
University of Texas Health Science Center, Division of Mood and Anxiety Disorders, 7526 Louis Pasteur Drive, San Antonio, TX 78229-3900, USA. tohen@uthscsa.edu
Mauricio
M
Tohen
David P
DP
McDonnell
Michael
M
Case
Shigenobu
S
Kanba
Kyooseob
K
Ha
Yi Ru
YR
Fang
Hideaki
H
Katagiri
Juan-Carlos
JC
Gomez
D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001569:Benzodiazepines / Q000008:administration & dosage* / Q000009:adverse effects; D001714:Bipolar Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D016896:Treatment Outcome; D055815:Young Adult
D014150:Antipsychotic Agents; D001569:Benzodiazepines; D000077152:Olanzapine