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

Arm | Intervention/treatment |
---|---|
Experimental: Quetiapine augmentation
Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage
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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
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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 |
- YBOCS [ Time Frame: 12 weeks ]difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score
- CGI [ Time Frame: 12 weeks ]Clinical Global Impression score for improvement at week 12
- Tolerability [ Time Frame: weeks 0,2,4,8 and 12 ]adverse events measure (emphasis in serotonergic syndrome)
- Cardiotoxicity [ Time Frame: week 0 and 2 ]Changes in baseline (week 0) EKG regarding QT interval

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Brazil | |
Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School | |
São Paulo, SP, Brazil, 05403-010 |
Principal Investigator: | Juliana B Diniz, MD | Department of Psychiatry University of São Paulo Medical School |
Publications:
Responsible Party: | Juliana Belo Diniz, MD, PhD, University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00564564 |
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 |
obsessive compulsive disorder pharmacological treatment quetiapine clomipramine SSRI |
Disease Compulsive Personality Disorder Obsessive-Compulsive Disorder Pathologic Processes Personality Disorders Mental Disorders Anxiety Disorders Quetiapine Fumarate Clomipramine Antidepressive Agents Psychotropic Drugs |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Antidepressive Agents, Tricyclic Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |