Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall study start date
01/05/2002
Overall study 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(s)
Patient
Age group
Not Specified
Sex
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
Study participating centre
MRC Research Unit on Anxiety Disorders
Cape Town
7505
South Africa
Sponsor information
Organisation
AstraZeneca (South Africa)
Sponsor details
5 Leeuwkop Road
Sunninghill
Johannesburg
2157
South Africa
Sponsor type
Industry
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 24/01/2005 | Yes | No |