| November 26, 2007 |
| February 4, 2008 |
| January 2006 |
| December 2007 (final data collection date for primary outcome measure) |
| difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] |
| percentage of reduction of initial Yale Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: 12 weeks ] |
| Complete list of historical versions of study NCT00564564 on ClinicalTrials.gov Archive Site |
- Clinical Global Impression score for improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- adverse events measure (emphasis in serotonergic syndrome) [ Time Frame: weeks 0,2,4,8 and 12 ] [ Designated as safety issue: Yes ]
- Changes in baseline (week 0) EKG regarding QT interval [ Time Frame: week 0 and 2 ] [ Designated as safety issue: Yes ]
|
| Clinical Global Impression score for improvement [ Time Frame: 12 weeks ] |
| |
| Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-Compulsive Disorder Patients |
| Quetiapine Augmentation Versus Clomipramine Augmentation of Selective Serotonin Reuptake Inhibitors for Obsessive-Compulsive Disorder Patients That do Not Respond to a SSRI Trial: a Randomized Open-Trial. |
The objective of this trial is to compare in an open trial format the efficacy of association of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete remission of obsessive compulsive disorder symptoms. |
The objective of this trial wis to compare in an randomized open trial format the efficacy of association of clomipramine at maximum dosage of 75mg per day and quetiapine at maximum dosage of 200mg per day with SSRI after SSRI treatment for 12 weeks failed to produce complete remission of OCD symptoms. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Obsessive Compulsive Disorder |
- Drug: Quetiapine
- Drug: Clomipramine
|
- Experimental: Quetiapine plus SSRI
- Active Comparator: Clomipramine plus SSRI
|
- Bloch MH, Landeros-Weisenberger A, Kelmendi B, Coric V, Bracken MB, Leckman JF. A systematic review: antipsychotic augmentation with treatment refractory obsessive-compulsive disorder. Mol Psychiatry. 2006 Jul;11(7):622-32. Epub 2006 Apr 4. Review. Erratum in: Mol Psychiatry. 2006 Aug;11(8):795.
- Browne M, Horn E, Jones TT. The benefits of clomipramine-fluoxetine combination in obsessive compulsive disorder. Can J Psychiatry. 1993 May;38(4):242-3.
- Denys D, de Geus F, van Megen HJ, Westenberg HG. A double-blind, randomized, placebo-controlled trial of quetiapine addition in patients with obsessive-compulsive disorder refractory to serotonin reuptake inhibitors. J Clin Psychiatry. 2004 Aug;65(8):1040-8.
- Fineberg NA, Sivakumaran T, Roberts A, Gale T. Adding quetiapine to SRI in treatment-resistant obsessive-compulsive disorder: a randomized controlled treatment study. Int Clin Psychopharmacol. 2005 Jul;20(4):223-6.
- Pallanti S, Quercioli L, Paiva RS, Koran LM. Citalopram for treatment-resistant obsessive-compulsive disorder. Eur Psychiatry. 1999 Apr;14(2):101-6.
|
| |
| Completed |
| 21 |
| December 2007 |
| December 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- primary OCD diagnosis according to DSM IV criteria
- current symptoms were responsible for significant distress
- previous trial of at least 12 weeks with SSRI (being at least 8 weeks at maximum tolerated dosage) failed to produce full remission of OCD symptoms
Exclusion Criteria:
- presence of clinical or neurological diseases that may be worsen by the medications included in treatment protocol
- current substance dependence or abuse,
- current psychotic symptoms
- current suicide risk
- and current pregnancy or intention to get pregnant before the end of the treatment protocol
|
| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Brazil |
| |
| NCT00564564 |
| Juliana Belo Diniz, University of São Paulo |
| 968/05, 2005/55628-08 (FAPESP) |
| University of Sao Paulo |
| CNPq |
| Principal Investigator: |
Juliana B Diniz, MD |
Department of Psychiatry University of São Paulo Medical School |
|
|
| University of Sao Paulo |
| February 2008 |
