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| Quetiapine augmentation to serotonin reuptake inhibitors for patients with obsessive compulsive disorder: a double-blind, placebo-controlled study |
| ISRCTN | ISRCTN40781401 |
| ClinicalTrials.gov identifier | |
| Public title | Quetiapine augmentation to serotonin reuptake inhibitors for patients with obsessive compulsive disorder: a double-blind, placebo-controlled study |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| 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) |
| Lay summary | |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| Study design | Randomised, placebo controlled, parallel group, double blinded trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Obsessive-Compulsive Disorder (OCD) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 18/11/2003 |
| Anticipated end date | 31/12/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 90 |
| 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 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. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding | AstraZeneca R&D Mölndal (Sweden) |
| Trial website | |
| Publications | |
| Contact name | Ms Nienke C C Vulink |
| Address |
University Medical Centre Utrecht (UMCU)
Department of Psychiatry Heidelberglaan 100 |
| City/town | Utrecht |
| Zip/Postcode | 3584 CX |
| Country | Netherlands |
| Tel | +31 (0)30 250 6370 |
| n.c.c.vulink@azu.nl | |
| Sponsor | University Medical Centre Utrecht (UMCU) (The Netherlands) |
| Address |
Department of Psychiatry
Heidelberglaan 100 |
| City/town | Utrecht |
| Zip/Postcode | 3584 CX |
| Country | Netherlands |
| Tel | +31 (0)30 250 9019 |
| h.g.m.westenberg@azu.nl | |
| Sponsor website: | http://www.umcutrecht.nl/zorg/ |
| Date applied | 23/02/2007 |
| Last edited | 17/10/2007 |
| Date ISRCTN assigned | 23/02/2007 |
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| © 2012 ISRCTN unless otherwise stated. | |
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