PMID- 20175941
OWN - NLM
STAT- MEDLINE
DCOM- 20110110
LR  - 20220311
IS  - 1469-5111 (Electronic)
IS  - 1461-1457 (Linking)
VI  - 13
IP  - 7
DP  - 2010 Aug
TI  - Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in 
      major depressive disorder (MDD) in patients with an inadequate response to 
      ongoing antidepressant treatment: a multicentre, randomized, double-blind, 
      placebo-controlled study.
PG  - 917-32
LID - 10.1017/S1461145710000015 [doi]
AB  - This study evaluated once-daily extended-release quetiapine fumarate (quetiapine 
      XR) as adjunctive therapy in patients with major depressive disorder (MDD) with 
      inadequate response to ongoing antidepressant treatment. In this 8-wk (6-wk 
      active treatment/2-wk post-treatment drug-discontinuation/follow-up), 
      multicentre, double-blind, placebo-controlled, Phase III study, 446 patients were 
      randomized to quetiapine XR 150 mg/d, 300 mg/d, or placebo adjunct to ongoing 
      antidepressant treatment. The primary endpoint was the change from randomization 
      to week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. At 
      week 6, MADRS total scores significantly improved with quetiapine XR 300 mg/d vs. 
      placebo (-14.7 vs. -11.7, p<0.01). Quetiapine XR 300 mg/d showed significant 
      improvements vs. placebo for: MADRS total score from week 1 onwards; MADRS 
      response [(> or = 50% total score reduction) 58.9% vs. 46.2%, p<0.05] and 
      remission [(total score < or = 8) 42.5% vs. 24.5%, p<0.01] rates; Hamilton 
      Depression Rating Scale (HAMD) (-13.53 vs. -10.80, p<0.01) and Clinical Global 
      Impression-Severity of illness (CGI-S) change (-1.52 vs. -1.23, p<0.05) at week 
      6. For quetiapine XR 150 mg/d, improvements were not significantly different vs. 
      placebo, except for MADRS (weeks 1 and 2) and HAMD (week 6) total scores. 
      Withdrawal rates due to adverse events (AEs) were: quetiapine XR 150 mg/d 11.5%, 
      300 mg/d 19.5%, and placebo 0.7%. The most common AEs (>10%) with quetiapine XR 
      were dry mouth, somnolence, sedation, dizziness, constipation, nausea, insomnia, 
      headache, and fatigue. In this study, quetiapine XR 300 mg/d as adjunctive 
      therapy in patients with MDD with an inadequate response to ongoing 
      antidepressant treatment was effective at week 6. However, the difference from 
      placebo for quetiapine XR 150 mg/d at week 6 was not statistically significant. 
      Both doses studied (150 and 300 mg/d) were effective at week 1 and generally well 
      tolerated.
FAU - El-Khalili, Nizar
AU  - El-Khalili N
AD  - Alpine Clinic, Lafayette, IN 47905, USA. elkhalilmd@aol.com
FAU - Joyce, Mark
AU  - Joyce M
FAU - Atkinson, Sarah
AU  - Atkinson S
FAU - Buynak, Robert J
AU  - Buynak RJ
FAU - Datto, Catherine
AU  - Datto C
FAU - Lindgren, Petter
AU  - Lindgren P
FAU - Eriksson, Hans
AU  - Eriksson H
LA  - eng
SI  - ClinicalTrials.gov/NCT00326105
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100223
PL  - England
TA  - Int J Neuropsychopharmacol
JT  - The international journal of neuropsychopharmacology
JID - 9815893
RN  - 0 (Antidepressive Agents)
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Dibenzothiazepines)
RN  - 2S3PL1B6UJ (Quetiapine Fumarate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antidepressive Agents/*therapeutic use
MH  - Antipsychotic Agents/administration & dosage/adverse effects/therapeutic use
MH  - Delayed-Action Preparations
MH  - Depressive Disorder, Major/*drug therapy
MH  - Dibenzothiazepines/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Quetiapine Fumarate
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2010/02/24 06:00
MHDA- 2011/01/11 06:00
CRDT- 2010/02/24 06:00
PHST- 2010/02/24 06:00 [entrez]
PHST- 2010/02/24 06:00 [pubmed]
PHST- 2011/01/11 06:00 [medline]
AID - S1461145710000015 [pii]
AID - 10.1017/S1461145710000015 [doi]
PST - ppublish
SO  - Int J Neuropsychopharmacol. 2010 Aug;13(7):917-32. doi: 
      10.1017/S1461145710000015. Epub 2010 Feb 23.