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Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-Compulsive Disorder Patients (QCAT)

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00564564
First received: November 26, 2007
Last updated: February 4, 2008
Last verified: February 2008
History of Changes
  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 4

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:

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:

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
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality 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 June 17, 2013