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

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder (OCD); Mental and Behavioural Disorders; Neurotic disorders

• Registration Number: ISRCTN40781401
• Lead Sponsor: niversity Medical Centre Utrecht (UMCU) (The Netherlands)

Brief Summary

2009 Results article in https://pubmed.ncbi.nlm.nih.gov/19497245/ (added 15/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-12-31
• Study Start: 2007-02-23
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 1. The onset of response to treatment, using the time to a sustained response as criterion<br> 2. Side effect profiles<br> 3. Quality of life<br> 4. Cognitive functioning<br>