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

Phase 4

Completed

• Conditions: Obsessive Compulsive Disorder
• Interventions: Drug: Clomipramine (fluoxetine plus clomipramine); Drug: Placebo (fluoxetine plus placebo); Drug: Quetiapine (fluoxetine plus quetiapine)

• Registration Number: NCT00466609
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

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 Timeline

• Study First Submitted: 2007-04-26
• Study First Submitted QC: 2007-04-26
• Study First Posted: 2007-04-27
• Study Start: 2007-05
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clomipramine (fluoxetine plus clomipramine)	Clomipramine (fluoxetine plus clomipramine)	Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks
Placebo (fluoxetine plus placebo)	Placebo (fluoxetine plus placebo)	Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks
Quetiapine (fluoxetine plus quetiapine)	Quetiapine (fluoxetine plus quetiapine)	fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks

Primary Outcome Measures

Name	Time	Method
YBOCS	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

Secondary Outcome Measures

Name	Time	Method
CGI	12 weeks	Clinical global impression measure of improvement
Cardiotoxicity	2 weeks	Change from baseline EKG regarding QT interval
Plasma levels	weeks 2 and 12	Fluoxetine dosage and Clomipramine plasmatic dosages (when applies)
Social Adaptation	12 weeks	Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman \& Payket, 1974) administered on weeks 0 and 12
BDI	12 weeks	Score obtained with Beck depression inventory (BDI)
QoL	12 weeks	Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.
Tolerability	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)
BAI	12 weeks	Score obtained with Beck´s anxiety inventory (BAI)

Trial Locations

Locations (1)

Institute of Psychiatry; 🇧🇷 Sao Paulo, SP, Brazil