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

October 26, 2017 updated by: Juliana Belo Diniz, University of Sao Paulo

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

54

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

    • SP
      • Sao Paulo, SP, Brazil, 05403-010
        • Institute of Psychiatry

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Quadruple

Arms and Interventions

Participant Group / 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
Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
Other Names:
  • 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
Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
Other Names:
  • 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
Placebo plus fluoxetine at maximum dosage of 80mg per day
Other Names:
  • Prozac
  • Daforin (EMS pharmaceutics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL
Time Frame: 12 weeks
Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.
12 weeks
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
12 weeks
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)
weeks 0,1,2,3,4,8,12
BDI
Time Frame: 12 weeks
Score obtained with Beck depression inventory (BDI)
12 weeks
BAI
Time Frame: 12 weeks
Score obtained with Beck´s anxiety inventory (BAI)
12 weeks
CGI
Time Frame: 12 weeks
Clinical global impression measure of improvement
12 weeks
Cardiotoxicity
Time Frame: 2 weeks
Change from baseline EKG regarding QT interval
2 weeks
Plasma levels
Time Frame: weeks 2 and 12
Fluoxetine dosage and Clomipramine plasmatic dosages (when applies)
weeks 2 and 12

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Juliana B Diniz, MD, University of Sao 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.

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

May 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 26, 2007

First Submitted That Met QC Criteria

April 26, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

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.

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