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

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ClinicalTrials.gov Identifier: NCT00564564
Recruitment Status : Completed
First Posted : November 28, 2007
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Juliana Belo Diniz, University of Sao Paulo

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Drug: Quetiapine Drug: Clomipramine Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : January 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Quetiapine augmentation
Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage
 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: Clomipramine augmentation
Clomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage
 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


Outcome Measures
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Primary Outcome Measures :
  1. YBOCS [ Time Frame: 12 weeks ]
    difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score


Secondary Outcome Measures :
  1. CGI [ Time Frame: 12 weeks ]
    Clinical Global Impression score for improvement at week 12

  2. Tolerability [ Time Frame: weeks 0,2,4,8 and 12 ]
    adverse events measure (emphasis in serotonergic syndrome)

  3. Cardiotoxicity [ Time Frame: week 0 and 2 ]
    Changes in baseline (week 0) EKG regarding QT interval


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
institutional site  This link exits the ClinicalTrials.gov site
Mains results  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Juliana Belo Diniz, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00564564     History of Changes
Other Study ID Numbers: 968/05
2005/55628-08 ( Other Grant/Funding Number: FAPESP )
First Posted: November 28, 2007    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Juliana Belo Diniz, University of Sao Paulo:
obsessive compulsive disorder
pharmacological treatment
quetiapine
clomipramine
SSRI

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Quetiapine Fumarate
Clomipramine
Serotonin Uptake Inhibitors
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents