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
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |

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
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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
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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
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Drug: Placebo (fluoxetine plus placebo)
Placebo plus fluoxetine at maximum dosage of 80mg per day
Other Names:
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- 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)

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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:
- 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

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
Brazil | |
Institute of Psychiatry | |
Sao Paulo, SP, Brazil, 05403-010 |
Principal Investigator: | Juliana B Diniz, MD | University of Sao Paulo Medical School |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Juliana Belo Diniz, MD, PhD, University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00466609 |
Other Study ID Numbers: |
05/55628-8 2005/55628-08 ( Other Grant/Funding Number: FAPESP ) |
First Posted: | April 27, 2007 Key Record Dates |
Last Update Posted: | October 30, 2017 |
Last Verified: | October 2017 |
clomipramine quetiapine fluoxetine |
placebo augmentation obsessive compulsive disorder |
Disease Compulsive Personality Disorder Obsessive-Compulsive Disorder Pathologic Processes Personality Disorders Mental Disorders Anxiety Disorders Quetiapine Fumarate Fluoxetine Clomipramine Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Antidepressive Agents, Second-Generation Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Antidepressive Agents, Tricyclic |