Condition category
Mental and Behavioural Disorders
Date applied
13/01/2005
Date assigned
13/01/2005
Last edited
11/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

AstraZeneca (South Africa)

Sponsor details

5 Leeuwkop Road
Sunninghill
Johannesburg
2157
South Africa

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/pubmed/15667657

Publication citations

  1. 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.

Additional files

Editorial Notes