Quetiapine augmentation to SRIs for patients with obsessive compulsive disorder: a double-blind, placebo-controlled study.

Quetiapine augmentation to SRIs for patients with obsessive compulsive disorder.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28722

Enrollment

Registered

2005-08-10

Start date

2003-11-18

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder.

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients meet the DSM IV criteria for obsessive-compulsive disorder; 2. Y-BOCS score > 16 if obsessions and compulsions; 3. Y-BOCS score > 10 if only obsessions; 4. Y-BOCS score > 10 if only compulsions; 5. Male and female, aged between 18-70 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

Exclusion criteria: 1. Presence of any of the following DSM IV conditions: a. Major depression (with a HDRS>17, [17 item]); b. Bipolar disorder; c. Schizophrenia or any other psychotic condition; d. Tic disorder, substance related disorder during the past 6 months; e. Epilepsy, or any structural 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 6 months before the screening visit; 7. Cognitive and behavioural treatment 3 months prior to the screening visit; 8. Any known contra-indication against citalopram or quetiapine.

Design outcomes

Primary

Measure	Time frame
The change in Yale Brown obsessive compulsive scale (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 CGI rating of much improved or very much improved.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactNienke C.C. Vulink

University Medical Center Utrecht (UMCU), Department of Psychiatry, Heidelberglaan 100

n.c.c.vulink@azu.nl+31 (0)30 2506370

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)