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Quetiapine augmentation of a serotonin reuptake inhibitor in treatment resistant obsessive-compulsive disorder: a multi-site, placebo-controlled study
ISRCTN ISRCTN83050762
DOI 10.1186/ISRCTN83050762
ClinicalTrials.gov identifier
EudraCT number
Public title Quetiapine augmentation of a serotonin reuptake inhibitor in treatment resistant obsessive-compulsive disorder: a multi-site, placebo-controlled study
Scientific title
Acronym N/A
Serial number at source 5077IL/9009
Study hypothesis Although serotonin reuptake inhibitors are effective in the treatment of obsessive-compulsive disorder (OCD), many patients fail to respond to these agents. Growing evidence from open-label and placebo-controlled trials suggests a role for augmentation of serotonin reuptake inhibitors (SRIs) with atypical antipsychotics in OCD. Quetiapine is generally well tolerated and previous open-label data has produced mixed results in OCD, and additional controlled data is needed.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Canada, South Africa
Disease/condition/study domain Obsessive-compulsive disorder
Participants - inclusion criteria Subjects with obsessive-compulsive disorder who failed at least one trial (12 weeks duration, of which six weeks at maximum tolerated dose) of a serotonin reuptake inhibitor.
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/05/2002
Anticipated end date 01/11/2003
Status of trial Completed
Patient information material
Target number of participants 42
Interventions Placebo-controlled, double-blind, flexible-dose augmentation with quetiapine of a serotonin reuptake inhibitor maintaned at the stable maximum tolerated dose.
Primary outcome measure(s) Not provided at time of registration.
Secondary outcome measure(s) Not provided at time of registration.
Sources of funding AstraZeneca Pharmaceuticals (South Africa)
Trial website
Publications Results in: http://www.ncbi.nlm.nih.gov/pubmed/15667657
Contact name Prof  Dan J  Stein
  Address MRC Research Unit on Anxiety Disorders
Department of Psychiatry
University of Stellenbosch
  City/town Cape Town
  Zip/Postcode 7505
  Country South Africa
  Tel +27 (0)21 938 9161
  Fax +27 (0)21 933 5790
  Email djs2@sun.ac.za
Sponsor AstraZeneca (South Africa)
  Address 5 Leeuwkop Road
Sunninghill
  City/town Johannesburg
  Zip/Postcode 2157
  Country South Africa
Date applied 13/01/2005
Last edited 11/08/2008
Date ISRCTN assigned 13/01/2005
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