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Sponsors and Collaborators: |
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo CNPq Novartis |
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Information provided by: | University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00466609 |
This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for OCD. The investigators will compare the association of an SSRI (fluoxetine) with quetiapine, SSRI with clomipramine and SSRI with placebo for 12 weeks.
Condition | Intervention | Phase |
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Obsessive Compulsive Disorder |
Drug: Association of clomipramine and fluoxetine Drug: Association of quetiapine and fluoxetine Drug: Association of placebo and fluoxetine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-Respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study |
Estimated Enrollment: | 90 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Quetiapine plus fluoxetine
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Drug: Association of quetiapine and fluoxetine
Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
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2: Experimental
Clomipramine plus fluoxetine
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Drug: Association of clomipramine and fluoxetine
Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
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3: Placebo Comparator
Placebo plus fluoxetine
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Drug: Association of placebo and fluoxetine
Placebo plus fluoxetine at maximum dosage of 80mg per day
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Arm 1: SSRI (Fluoxetine 40mg* once a day) + Clomipramine 75mg* once a day. Arm 2: SSRI (Fluoxetine 40mg* once a day) + Quetiapine 200mg* once a day. Arm 3: SSRI (Fluoxetine 80mg* once a day) + Placebo once a day.
* or maximum tolerated dose
We hypothesize that quetiapine and clomipramine will be effective augmentation strategies for resistant OCD patients in comparison to placebo
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Izabel Pimentel, Nurse | 5511 30696972 ext 169 | izabelpimentel@terra.com.br |
Contact: Juliana Diniz, MD | 5511 30696972 ext 170 | juliana@protoc.com.br |
Brazil, SP | |
Institute of Psychiatry | Recruiting |
Sao Paulo, SP, Brazil, 05403-010 |
Principal Investigator: | Juliana B Diniz, MD | University of Sao Paulo Medical School |
Responsible Party: | University of São Paulo ( Juliana Belo Diniz ) |
Study ID Numbers: | 05/55628-8, 2005/55628-08 |
Study First Received: | April 26, 2007 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00466609 |
Health Authority: | Brazil: National Committee of Ethics in Research |
clomipramine quetiapine fluoxetine |
placebo augmentation obsessive compulsive disorder |
Fluoxetine Quetiapine Anxiety Disorders Mental Disorders |
Clomipramine Serotonin Obsessive-Compulsive Disorder |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Antidepressive Agents, Tricyclic Pathologic Processes Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |