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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 improvement

adverse 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

Page last updated: August 23, 2015

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