PMID- 18452345
OWN - NLM
STAT- MEDLINE
DCOM- 20080903
LR  - 20190902
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 69
IP  - 5
DP  - 2008 May
TI  - Efficacy of quetiapine monotherapy for the treatment of depressive episodes in 
      bipolar I disorder: a post hoc analysis of combined results from 2 double-blind, 
      randomized, placebo-controlled studies.
PG  - 769-82
AB  - OBJECTIVE: To investigate the efficacy and tolerability of quetiapine monotherapy 
      for the treatment of major depressive episodes in patients with bipolar I 
      disorder, as a post hoc analysis of data from 2 large studies, the BipOLar 
      DEpRession (BOLDER) I and II studies, which investigated the overall efficacy of 
      quetiapine in both bipolar I and II disorder. METHOD: A combined cohort of 
      patients with depressive episodes in bipolar I disorder (DSM-IV criteria) (N = 
      694) from 2 nearly identical double-blind, randomized, placebo-controlled studies 
      that each randomly assigned patients with bipolar I and II disorder to 8 weeks of 
      treatment with quetiapine 300 or 600 mg/day or placebo was analyzed. The primary 
      efficacy measure was change from baseline to end of treatment (week 8) in the 
      Montgomery-Asberg Depression Rating Scale (MADRS) total scores. RESULTS: In the 
      combined cohort of patients with depressive episodes in bipolar I disorder from 2 
      studies, there were significantly greater clinical improvements in mean MADRS 
      total scores among patients who received quetiapine compared with placebo from 
      baseline to week 1 and through week 8 (at week 8: quetiapine 300 mg/day = -19.4; 
      600 mg/day = -19.6; placebo = -12.6; p < .001 for each dose), providing effect 
      sizes of 0.78 and 0.80, respectively. Changes in MADRS were unrelated to reports 
      of sedation and somnolence. The most common adverse events (AEs) with quetiapine 
      were dry mouth, somnolence, sedation, dizziness, and constipation. Rates of 
      withdrawal because of these AEs were relatively low. CONCLUSIONS: Quetiapine 
      monotherapy (300 and 600 mg/day) is more effective than placebo and generally 
      well tolerated for the treatment of depressive episodes in patients with bipolar 
      I disorder.
FAU - Weisler, Richard H
AU  - Weisler RH
AD  - Department of Psychiatry and Behavioral Science, Duke University Medical Center, 
      University of North Carolina at Chapel Hill, Raleigh, NC 27609, USA. 
      RWeisler@aol.com
FAU - Calabrese, Joseph R
AU  - Calabrese JR
FAU - Thase, Michael E
AU  - Thase ME
FAU - Arvekvist, Robert
AU  - Arvekvist R
FAU - Stening, Goran
AU  - Stening G
FAU - Paulsson, Bjorn
AU  - Paulsson B
FAU - Suppes, Trisha
AU  - Suppes T
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Dibenzothiazepines)
RN  - 2S3PL1B6UJ (Quetiapine Fumarate)
SB  - IM
MH  - Adult
MH  - Antipsychotic Agents/*therapeutic use
MH  - Bipolar Disorder/diagnosis/*epidemiology
MH  - Depressive Disorder, Major/diagnosis/*drug therapy/*epidemiology
MH  - Diagnostic and Statistical Manual of Mental Disorders
MH  - Dibenzothiazepines/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Mass Screening
MH  - Quetiapine Fumarate
MH  - Treatment Outcome
EDAT- 2008/05/03 09:00
MHDA- 2008/09/04 09:00
CRDT- 2008/05/03 09:00
PHST- 2008/05/03 09:00 [pubmed]
PHST- 2008/09/04 09:00 [medline]
PHST- 2008/05/03 09:00 [entrez]
AID - ej07m03676 [pii]
AID - 10.4088/jcp.v69n0510 [doi]
PST - ppublish
SO  - J Clin Psychiatry. 2008 May;69(5):769-82. doi: 10.4088/jcp.v69n0510.