- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00466609
Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment (EPMTOC)
October 26, 2017 updated by: Juliana Belo Diniz, University of Sao Paulo
Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study
This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line pharmacological treatment.
The investigators will compare: fluoxetine maintenance at maximum dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the association of fluoxetine with clomipramine.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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SP
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Sao Paulo, SP, Brazil, 05403-010
- Institute of Psychiatry
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- OCD diagnosis
- YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions)
- Previously signed informed consent to participate in this clinical trial
Exclusion Criteria:
- Patients with 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
- Current pregnancy or intention to get pregnant before the end of the treatment protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quetiapine (fluoxetine plus quetiapine)
fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks
|
Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
Other Names:
|
Active Comparator: Clomipramine (fluoxetine plus clomipramine)
Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks
|
Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
Other Names:
|
Placebo Comparator: Placebo (fluoxetine plus placebo)
Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks
|
Placebo plus fluoxetine at maximum dosage of 80mg per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
YBOCS
Time Frame: 12 weeks
|
Rates of improvement after 12 weeks of treatment based on the difference of initial and final Yale Brown Obsessive Compulsive Scale (YBOCS) scores for obsessions and compulsions
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QoL
Time Frame: 12 weeks
|
Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.
|
12 weeks
|
Social Adaptation
Time Frame: 12 weeks
|
Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12
|
12 weeks
|
Tolerability
Time Frame: weeks 0,1,2,3,4,8,12
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Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome)
|
weeks 0,1,2,3,4,8,12
|
BDI
Time Frame: 12 weeks
|
Score obtained with Beck depression inventory (BDI)
|
12 weeks
|
BAI
Time Frame: 12 weeks
|
Score obtained with Beck´s anxiety inventory (BAI)
|
12 weeks
|
CGI
Time Frame: 12 weeks
|
Clinical global impression measure of improvement
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12 weeks
|
Cardiotoxicity
Time Frame: 2 weeks
|
Change from baseline EKG regarding QT interval
|
2 weeks
|
Plasma levels
Time Frame: weeks 2 and 12
|
Fluoxetine dosage and Clomipramine plasmatic dosages (when applies)
|
weeks 2 and 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Juliana B Diniz, MD, University of Sao Paulo Medical School
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Diniz JB, Shavitt RG, Fossaluza V, Koran L, Pereira CA, Miguel EC. A double-blind, randomized, controlled trial of fluoxetine plus quetiapine or clomipramine versus fluoxetine plus placebo for obsessive-compulsive disorder. J Clin Psychopharmacol. 2011 Dec;31(6):763-8. doi: 10.1097/JCP.0b013e3182367aee.
- Fossaluza V, Diniz JB, Pereira Bde B, Miguel EC, Pereira CA. Sequential allocation to balance prognostic factors in a psychiatric clinical trial. Clinics (Sao Paulo). 2009;64(6):511-8. doi: 10.1590/s1807-59322009000600005.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
April 26, 2007
First Submitted That Met QC Criteria
April 26, 2007
First Posted (Estimate)
April 27, 2007
Study Record Updates
Last Update Posted (Actual)
October 30, 2017
Last Update Submitted That Met QC Criteria
October 26, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Personality Disorders
- Anxiety Disorders
- Disease
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Antidepressive Agents, Tricyclic
- Cytochrome P-450 CYP2D6 Inhibitors
- Clomipramine
- Quetiapine Fumarate
- Fluoxetine
Other Study ID Numbers
- 05/55628-8
- 2005/55628-08 (Other Grant/Funding Number: FAPESP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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