Contact information
Type
Scientific
Primary contact
Prof Dan J Stein
ORCID ID
Contact details
MRC Research Unit on Anxiety Disorders
Department of Psychiatry
University of Stellenbosch
Cape Town
7505
South Africa
+27 (0)21 938 9161
djs2@sun.ac.za
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5077IL/9009
Study information
Scientific title
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Obsessive-compulsive disorder
Intervention
Placebo-controlled, double-blind, flexible-dose augmentation with quetiapine of a serotonin reuptake inhibitor maintaned at the stable maximum tolerated dose.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/05/2002
Overall trial end date
01/11/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
42
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2002
Recruitment end date
01/11/2003
Locations
Countries of recruitment
Canada, South Africa
Trial participating centre
MRC Research Unit on Anxiety Disorders
Cape Town
7505
South Africa
Funders
Funder type
Industry
Funder name
AstraZeneca Pharmaceuticals (South Africa)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in: http://www.ncbi.nlm.nih.gov/pubmed/15667657
Publication citations
-
Results
Carey PD, Vythilingum B, Seedat S, Muller JE, van Ameringen M, Stein DJ, Quetiapine augmentation of SRIs in treatment refractory obsessive-compulsive disorder: a double-blind, randomised, placebo-controlled study [ISRCTN83050762]., BMC Psychiatry, 2005, 5, 5, doi: 10.1186/1471-244X-5-5.