Obsessive-Compulsive Disorder (OCD) Mental and Behavioural Disorders Neurotic disorders
Conditions
Sponsors
University Medical Centre Utrecht (UMCU) (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| 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 | — |
Countries
Netherlands
Outcome results
None listed