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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00466609
First Posted: April 27, 2007
Last Update Posted: May 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]
  • Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12 [ Time Frame: 12 weeks ]
  • 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 ]
  • Score obtained with Beck depression inventory (BDI) [ Time Frame: 12 weeks ]
  • Score obtained with Beck´s anxiety inventory (BAI) [ Time Frame: 12 weeks ]
  • Clinical global impression measure of improvement [ Time Frame: 12 weeks ]
  • Change from baseline EKG regarding QT interval [ Time Frame: 2 weeks ]
  • Fluoxetine dosage and Clomipramine dosage (when applies) [ Time Frame: weeks 2 and 12 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: April 26, 2007
First Posted: April 27, 2007
Last Update Posted: May 13, 2010
Last Verified: May 2010

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

Additional relevant MeSH terms:
Fluoxetine
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Quetiapine Fumarate
Clomipramine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antidepressive Agents, Tricyclic