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Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-Compulsive Disorder Patients (QCAT)
This study has been completed.
Sponsor:
University of Sao Paulo
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
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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 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:
Clomipramine
Clomipramine hydrochloride
Quetiapine
Quetiapine fumarate
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 ]
Secondary Outcome Measures:
- Clinical Global Impression score for improvement [ Time Frame: 12 weeks ]
- adverse events measure (emphasis in serotonergic syndrome) [ Time Frame: weeks 0,2,4,8 and 12 ]
- Changes in baseline (week 0) EKG regarding QT interval [ Time Frame: week 0 and 2 ]
| 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 (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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564564
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 |
Keywords provided by University of Sao Paulo:
|
obsessive compulsive disorder pharmacological treatment quetiapine clomipramine SSRI |
Additional relevant MeSH terms:
|
Disease Compulsive Personality Disorder Obsessive-Compulsive Disorder Compulsive Behavior Pathologic Processes Personality Disorders Mental Disorders Anxiety Disorders Impulsive Behavior Clomipramine Serotonin Uptake Inhibitors Quetiapine Fumarate |
Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 23, 2017