Condition category
Mental and Behavioural Disorders
Date applied
23/02/2007
Date assigned
23/02/2007
Last edited
17/10/2007
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

Ms Nienke C C Vulink

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
Department of Psychiatry
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 (0)30 250 6370
n.c.c.vulink@azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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

Ethics approval received from the local medical ethics committee

Study design

Randomised, placebo controlled, parallel group, double blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Quetiapine

Primary outcome measures

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 trial start date

18/11/2003

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

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

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3584 CX
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

Department of Psychiatry
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 (0)30 250 9019
h.g.m.westenberg@azu.nl

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Industry

Funder name

AstraZeneca R&D Mölndal (Sweden)

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

Publication citations

Additional files

Editorial Notes