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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Dan J Stein
Scientific

MRC Research Unit on Anxiety Disorders
Department of Psychiatry
University of Stellenbosch
Cape Town
7505
South Africa

Phone	+27 (0)21 938 9161
Email	djs2@sun.ac.za

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

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

MRC Research Unit on Anxiety Disorders

Cape Town
7505
South Africa

AstraZeneca (South Africa)
Industry

5 Leeuwkop Road
Sunninghill
Johannesburg
2157
South Africa

"ROR"	https://ror.org/04r9x1a08

Industry

AstraZeneca Pharmaceuticals (South Africa)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	24/01/2005		Yes	No