Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment (EPMTOC)
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|ClinicalTrials.gov Identifier: NCT00466609|
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : October 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obsessive Compulsive Disorder||Drug: Clomipramine (fluoxetine plus clomipramine) Drug: Quetiapine (fluoxetine plus quetiapine) Drug: Placebo (fluoxetine plus placebo)||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||April 2010|
Experimental: Quetiapine (fluoxetine plus quetiapine)
fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks
Drug: Quetiapine (fluoxetine plus quetiapine)
Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
Other Name: Seroquel
Active Comparator: Clomipramine (fluoxetine plus clomipramine)
Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks
Drug: Clomipramine (fluoxetine plus clomipramine)
Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
Other Name: Anafranil
Placebo Comparator: Placebo (fluoxetine plus placebo)
Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks
Drug: Placebo (fluoxetine plus placebo)
Placebo plus fluoxetine at maximum dosage of 80mg per day
- 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
- QoL [ Time Frame: 12 weeks ]Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.
- 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
- Tolerability [ Time Frame: weeks 0,1,2,3,4,8,12 ]Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome)
- BDI [ Time Frame: 12 weeks ]Score obtained with Beck depression inventory (BDI)
- BAI [ Time Frame: 12 weeks ]Score obtained with Beck´s anxiety inventory (BAI)
- CGI [ Time Frame: 12 weeks ]Clinical global impression measure of improvement
- Cardiotoxicity [ Time Frame: 2 weeks ]Change from baseline EKG regarding QT interval
- Plasma levels [ Time Frame: weeks 2 and 12 ]Fluoxetine dosage and Clomipramine plasmatic dosages (when applies)
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): NCT00466609
|Institute of Psychiatry|
|Sao Paulo, SP, Brazil, 05403-010|
|Principal Investigator:||Juliana B Diniz, MD||University of Sao Paulo Medical School|