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

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Novartis
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00466609
First received: April 26, 2007
Last updated: May 12, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Obsessive Compulsive Disorder
Drug: clomipramine and fluoxetine
Drug: quetiapine and fluoxetine
Drug: placebo and fluoxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12; [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome) [ Time Frame: weeks 0,1,2,3,4,8,12 ] [ Designated as safety issue: Yes ]
  • Score obtained with Beck depression inventory (BDI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Score obtained with Beck´s anxiety inventory (BAI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical global impression measure of improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline EKG regarding QT interval [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Fluoxetine dosage and Clomipramine dosage (when applies) [ Time Frame: weeks 2 and 12 ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: May 2007
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quetiapine augmentation
fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks
Drug: quetiapine and fluoxetine
Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
Other Name: Seroquel
Experimental: Clomipramine augmentation
Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks
Drug: clomipramine and fluoxetine
Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
Other Name: Anafranil
Placebo Comparator: Placebo
Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks
Drug: placebo and fluoxetine
Placebo plus fluoxetine at maximum dosage of 80mg per day
Other Names:
  • Prozac
  • Daforin (EMS pharmaceutics)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466609

Locations
Brazil
Institute of Psychiatry
Sao Paulo, SP, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Novartis
Investigators
Principal Investigator: Juliana B Diniz, MD University of Sao Paulo Medical School
  More Information

Additional Information:
No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juliana Belo Diniz, University of São Paulo
ClinicalTrials.gov Identifier: NCT00466609     History of Changes
Other Study ID Numbers: 05/55628-8, 2005/55628-08
Study First Received: April 26, 2007
Last Updated: May 12, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
clomipramine
quetiapine
fluoxetine
placebo
augmentation
obsessive compulsive disorder

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Quetiapine
Fluoxetine
Clomipramine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Antidepressive Agents, Tricyclic

ClinicalTrials.gov processed this record on September 18, 2014