Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-compulsive Disorder Patients

Phase 4

Completed

• Conditions: Obsessive Compulsive Disorder
• Interventions: Drug: Clomipramine; Drug: Quetiapine

• Registration Number: NCT00564564
• Lead Sponsor: University of Sao Paulo

Brief Summary

The objective of this trial is to compare in an open trial format the efficacy of association of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete remission of obsessive compulsive disorder symptoms.

Detailed Description

The objective of this trial wis to compare in an randomized open trial format the efficacy of association of clomipramine at maximum dosage of 75mg per day and quetiapine at maximum dosage of 200mg per day with SSRI after SSRI treatment for 12 weeks failed to produce complete remission of OCD symptoms.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-11-26
• Study First Submitted QC: 2007-11-26
• Study First Posted: 2007-11-28
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• primary OCD diagnosis according to DSM IV criteria
• current symptoms were responsible for significant distress
• previous trial of at least 12 weeks with SSRI (being at least 8 weeks at maximum tolerated dosage) failed to produce full remission of OCD symptoms

Exclusion Criteria

• presence of 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
• and 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 augmentation	Clomipramine	Clomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage
Quetiapine augmentation	Quetiapine	Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage

Primary Outcome Measures

Name	Time	Method
YBOCS	12 weeks	difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score

Secondary Outcome Measures

Name	Time	Method
CGI	12 weeks	Clinical Global Impression score for improvement at week 12
Tolerability	weeks 0,2,4,8 and 12	adverse events measure (emphasis in serotonergic syndrome)
Cardiotoxicity	week 0 and 2	Changes in baseline (week 0) EKG regarding QT interval

Trial Locations

Locations (1)

Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School; 🇧🇷 São Paulo, SP, Brazil