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

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ClinicalTrials.gov Identifier: NCT00466609
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Novartis
Information provided by (Responsible Party):
Juliana Belo Diniz, University of Sao Paulo

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Drug: Clomipramine (fluoxetine plus clomipramine) Drug: Quetiapine (fluoxetine plus quetiapine) Drug: Placebo (fluoxetine plus placebo) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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
Study Start Date : May 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Drug: Quetiapine (fluoxetine plus quetiapine)
Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
Other Name: 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
 Drug: Clomipramine (fluoxetine plus clomipramine)
Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
Other Name: 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
 Drug: Placebo (fluoxetine plus placebo)
Placebo plus fluoxetine at maximum dosage of 80mg per day
Other Names:
  • Prozac
  • Daforin (EMS pharmaceutics)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. QoL [ Time Frame: 12 weeks ]
    Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.

  2. 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

  3. 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)

  4. BDI [ Time Frame: 12 weeks ]
    Score obtained with Beck depression inventory (BDI)

  5. BAI [ Time Frame: 12 weeks ]
    Score obtained with Beck´s anxiety inventory (BAI)

  6. CGI [ Time Frame: 12 weeks ]
    Clinical global impression measure of improvement

  7. Cardiotoxicity [ Time Frame: 2 weeks ]
    Change from baseline EKG regarding QT interval

  8. Plasma levels [ Time Frame: weeks 2 and 12 ]
    Fluoxetine dosage and Clomipramine plasmatic dosages (when applies)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Institutional site of main sponsor  This link exits the ClinicalTrials.gov site
Main results  This link exits the ClinicalTrials.gov site
Secondary analysis results  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Juliana Belo Diniz, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00466609     History of Changes
Other Study ID Numbers: 05/55628-8
2005/55628-08 ( Other Grant/Funding Number: FAPESP )
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by Juliana Belo Diniz, 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 Fumarate
Fluoxetine
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