Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-Compulsive Disorder Patients - Full Text View

Sponsor:	University of Sao Paulo
Collaborator:	Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00564564

Purpose

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.

Condition	Intervention	Phase
Obsessive Compulsive Disorder	Drug: Quetiapine Drug: Clomipramine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Serotonin Clomipramine hydrochloride Quetiapine Quetiapine fumarate Clomipramine

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	21
Study Start Date:	January 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Quetiapine plus SSRI	Drug: Quetiapine Quetiapine once a day at maximum dosage of 200mg per day asociated to a SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram) Other Name: Seroquel
Active Comparator: 2 Clomipramine plus SSRI	Drug: Clomipramine Clomipramine once a day at maximum dosage of 75mg per day plus SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram) Other Name: Anafranil

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564564

Locations

Brazil
Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School
São Paulo, SP, Brazil, 05403-010

Sponsors and Collaborators

University of Sao Paulo

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Principal Investigator:

Juliana B Diniz, MD

Department of Psychiatry University of São Paulo Medical School

More Information

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.

Responsible Party:	Juliana Belo Diniz, University of São Paulo
ClinicalTrials.gov Identifier:	NCT00564564 History of Changes
Other Study ID Numbers:	968/05, 2005/55628-08 (FAPESP)
Study First Received:	November 26, 2007
Last Updated:	February 4, 2008
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:

obsessive compulsive disorder
pharmacological treatment
quetiapine
clomipramine
SSRI

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Clomipramine
Serotonin Uptake Inhibitors
Quetiapine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 09, 2012