Quetiapine augmentation of a serotonin reuptake inhibitor in treatment resistant obsessive-compulsive disorder: a multi-site, placebo-controlled study
| ISRCTN | ISRCTN83050762 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83050762 |
| Secondary identifying numbers | 5077IL/9009 |
- Submission date
- 13/01/2005
- Registration date
- 13/01/2005
- Last edited
- 11/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Dan J Stein
Scientific
Scientific
MRC Research Unit on Anxiety Disorders
Department of Psychiatry
University of Stellenbosch
Cape Town
7505
South Africa
| Phone | +27 (0)21 938 9161 |
|---|---|
| djs2@sun.ac.za |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 42 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2002 |
| Date of final enrolment | 01/11/2003 |
Locations
Countries of recruitment
- Canada
- South Africa
Study participating centre
MRC Research Unit on Anxiety Disorders
Cape Town
7505
South Africa
7505
South Africa
Sponsor information
AstraZeneca (South Africa)
Industry
Industry
5 Leeuwkop Road
Sunninghill
Johannesburg
2157
South Africa
"ROR" |
https://ror.org/04r9x1a08 |
|---|
Funders
Funder type
Industry
AstraZeneca Pharmaceuticals (South Africa)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 24/01/2005 | Yes | No |
