Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment - Full Text View

Sponsor:	University of Sao Paulo
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

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 IV

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:

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder

Drug Information available for: Clomipramine hydrochloride Fluoxetine Fluoxetine hydrochloride Quetiapine Quetiapine fumarate Clomipramine

U.S. FDA Resources

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:

OCD diagnosis
YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions)
Previously signed informed consent to participate in this clinical trial

Exclusion Criteria:

Patients with 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
Current pregnancy or intention to get pregnant before the end of the treatment protocol

Contacts and Locations

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:

Main research group involved in this study This link exits the ClinicalTrials.gov site

Institutional site of main sponsor This link exits the ClinicalTrials.gov site

No publications provided by University of Sao Paulo

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

Diniz JB, Shavitt RG, Fossaluza V, Koran L, Pereira CA, Miguel EC. A double-blind, randomized, controlled trial of fluoxetine plus quetiapine or clomipramine versus fluoxetine plus placebo for obsessive-compulsive disorder. J Clin Psychopharmacol. 2011 Dec;31(6):763-8.

Fossaluza V, Diniz JB, Pereira Bde B, Miguel EC, Pereira CA. Sequential allocation to balance prognostic factors in a psychiatric clinical trial. Clinics (Sao Paulo). 2009;64(6):511-8.

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:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Clomipramine
Fluoxetine
Quetiapine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 13, 2012