Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-Compulsive Disorder Patients
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive Compulsive Disorder
Intervention: Quetiapine (Drug); Clomipramine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s): Juliana B Diniz, MD, Principal Investigator, Affiliation: Department of Psychiatry University of São Paulo Medical School
Summary
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.
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score
Secondary outcome: Clinical Global Impression score for improvementadverse events measure (emphasis in serotonergic syndrome) Changes in baseline (week 0) EKG regarding QT interval
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School, São Paulo, SP 05403-010, Brazil
Additional Information
Related publications: 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.
Starting date: January 2006
Last updated: February 4, 2008
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