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Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obsessive Compulsive Disorder

Intervention: clomipramine and fluoxetine (Drug); quetiapine and fluoxetine (Drug); placebo and fluoxetine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
Juliana B Diniz, MD, Principal Investigator, Affiliation: University of Sao Paulo Medical School


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.

Clinical Details

Official title: Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12;

Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12

Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome)

Score obtained with Beck depression inventory (BDI)

Score obtained with Beck´s anxiety inventory (BAI)

Clinical global impression measure of improvement

Change from baseline EKG regarding QT interval

Fluoxetine dosage and Clomipramine dosage (when applies)

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: 1. OCD diagnosis 2. YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions) 3. Previously signed informed consent to participate in this clinical trial Exclusion Criteria: 1. Patients with clinical or neurological diseases that may be worsen by the medications included in treatment protocol 2. Current substance dependence or abuse 3. Current psychotic symptoms 4. Current suicide risk 5. Current pregnancy or intention to get pregnant before the end of the treatment protocol

Locations and Contacts

Institute of Psychiatry, Sao Paulo, SP 05403-010, Brazil
Additional Information

Main research group involved in this study

Institutional site of main sponsor

Starting date: May 2007
Last updated: May 12, 2010

Page last updated: August 23, 2015

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