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

October 25, 2017 updated by: Juliana Belo Diniz, University of Sao Paulo

Quetiapine Augmentation Versus Clomipramine Augmentation of Selective Serotonin Reuptake Inhibitors for Obsessive-compulsive Disorder Patients That do Not Respond to a SSRI Trial: a Randomized Open-trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403-010
        • Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quetiapine augmentation
Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage
Drug: Quetiapine
Quetiapine once a day at maximum dosage of 200mg per day asociated to a SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram)
Other Names:
  • Seroquel
Active Comparator: Clomipramine augmentation
Clomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage
Drug: Clomipramine
Clomipramine once a day at maximum dosage of 75mg per day plus SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram)
Other Names:
  • Anafranil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
YBOCS
Time Frame: 12 weeks
difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Juliana B Diniz, MD, Department of Psychiatry University of São Paulo Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 26, 2007

First Submitted That Met QC Criteria

November 26, 2007

First Posted (Estimate)

November 28, 2007

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 968/05
  • 2005/55628-08 (Other Grant/Funding Number: FAPESP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obsessive Compulsive Disorder

Clinical Trials on Quetiapine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe