Quetiapine augmentation to serotonin reuptake inhibitors for patients with obsessive compulsive disorder: a double-blind, placebo-controlled study

ISRCTN	ISRCTN40781401
DOI	https://doi.org/10.1186/ISRCTN40781401
Secondary identifying numbers	N/A

Submission date: 23/02/2007
Registration date: 23/02/2007
Last edited: 15/07/2021

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

Not provided at time of registration

Contact information

Ms Nienke C C Vulink
Scientific

University Medical Centre Utrecht (UMCU)
Department of Psychiatry
Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Phone	+31 (0)30 250 6370
Email	n.c.c.vulink@azu.nl

Study information

Study design	Randomised, placebo controlled, parallel group, double blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	Quetiapine augmentation to serotonin reuptake inhibitors for patients with obsessive compulsive disorder: a double-blind, placebo-controlled study
Study hypothesis	Although Serotonin Reuptake Inhibitors (SRIs) are the most effective pharmacologic treatment currently available for patients with Obsessive-Compulsive Disorder (OCD), 40% to 60% of patients do not respond to this treatment. This study was conducted to evaluate the efficacy and tolerability of quetiapine in addition to an SRI for medication-naive or free patients with OCD. Hypotheses: To determine the efficacy of quetiapine as an adjunct to patients with OCD, without comorbitity, who are newly diagnosed, medication-naive or free. The following hypotheses will be tested: 1. Addition of quetiapine to a SRI increases the number of responders to treatment 2. Addition of quetiapine to a SRI decreases the time to response 3. Addition of quetiapine to a SRI increases the effect size as measured with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Condition	Obsessive-Compulsive Disorder (OCD)
Intervention	The trial will be a randomised, double-blind, placebo-controlled, fixed dose study with quetiapine as adjunct to a SRI administered at the maximum tolerable dosage. Fluoxetine and venlafaxine will be excluded. Ninety patients with OCD will be recruited and randomly allocated to receive either an SRI with placebo or an SRI with quetiapine for 10 weeks. Both patient and investigator will be blind to the drug assignment.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Quetiapine
Primary outcome measure	The change in Y-BOCS from baseline to week 10 and the number of responders are the primary efficacy parameters. Criteria for response will be a 25% or greater change from baseline on the Y-BOCS and a final Clinical Global Impression (CGI) rating of much improved or very much improved.
Secondary outcome measures	1. The onset of response to treatment, using the time to a sustained response as criterion 2. Side effect profiles 3. Quality of life 4. Cognitive functioning
Overall study start date	18/11/2003
Overall study end date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	90
Total final enrolment	76
Participant inclusion criteria	1. All patients meet the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM IV) criteria for obsessive-compulsive disorder 2. Y-BOCS score more than 16 if obsessions and compulsions 3. Y-BOCS score more than 10 if only obsessions 4. Y-BOCS score more than 10 if only compulsions 5. Male and female, aged between 18 and 70 years 6. Female patients of childbearing potential must have a negative pregnancy test and use a reliable method of contraception 7. Written informed consent
Participant exclusion criteria	1. Presence of any of the following DSM IV conditions: 1.1. Major depression (with a Hamilton Depression Rating Scale [HDRS] more than 17 [17 item]) 1.2. Bipolar disorder 1.3. Schizophrenia or any other psychotic condition 1.4. Tic disorder, substance related disorder during the past six months 1.5. Epilepsy, or any structural Central Nervous System (CNS) disorder or stroke within the last year 2. Evidence of clinically significant and unstable cardiovascular, gastro-intestinal, pulmonary, renal, hepatic, endocrine or haematological disorders 3. Glaucome, myocardial infarction within the past year, or micturition abnormalities 4. Patients at risk for suicide 5. Multiple serious drug allergies or known allergy for the trial compounds 6. Use of antipsychotics during six months before the screening visit 7. Cognitive and behavioural treatment three months prior to the screening visit 8. Any known contra-indication against citalopram or quetiapine
Recruitment start date	18/11/2003
Recruitment end date	31/12/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Centre Utrecht (UMCU)

Utrecht
3584 CX
Netherlands

Sponsor information

University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre

Department of Psychiatry
Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Phone	+31 (0)30 250 9019
Email	h.g.m.westenberg@azu.nl
Website	http://www.umcutrecht.nl/zorg/
"ROR"	https://ror.org/04pp8hn57

Funders

Funder type

Industry

AstraZeneca R&D Mölndal (Sweden)

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		01/07/2009	15/07/2021	Yes	No

Editorial Notes

15/07/2021: Publication reference and total final enrolment added.