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Group Cognitive Behavioral Therapy (CBT) Versus Fluoxetine for OCD: a Pratical Trial (GCBT)
This study is currently recruiting participants.
Verified by University of Sao Paulo, May 2008
Sponsors and Collaborators: University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by: University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00680602
  Purpose

First line treatments fo Obsessive Compulsive Disorder (OCD) are Selective Serotonin Recaptation Inhibitors (SSRIs) and Cognitive Behaviour Therapy (CBT) including exposure with response prevention. The aim of the present study is to evaluate the clinical efficacy of Group Cognitive Behaviour Therapy (GCBT) and Selective Serotonin Recaptation Inhibitors (SSRIs) for OCD patients. Other clinical trials have compared these treatments, but with OCD patients without any other psychiatric disorder. In this study patients with current age between 18 and 65 years, with YBOCS score of at least 16 and psychiatric comorbidities will be not excluded. Exclusion criteria will be: OCD secondary to brain trauma, stroke or malformation; current abuse of alcohol or other psychoactive substance, current presence of psychotic symptoms, suicidal risk, psychiatric or clinical comorbidity that might get worse with the medications used in the trial. So, the present study investigates the efficacy of these treatments for a heterogeneous OCD population, trying to identify if the usual treatments are efficient when applied in the public health system that treat not just patients with only OCD diagnosis. Patients will be randomized for GCBT and SSRI, and after treatment will be evaluated by researchers blind to the treatment received.


Condition Intervention Phase
Obsessive Compulsive Disorder
Behavioral: Group Cognitive Behavior Therapy
Drug: SSRI (fluoxetine, sertraline, paroxetine, citalopram)
Phase IV

MedlinePlus related topics: Obsessive-Compulsive Disorder
Drug Information available for: Sertraline hydrochloride Sertraline Fluoxetine Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Fluoxetine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Randomized Open Trial for Any Patient.

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) (Goodman et al., 1989) and Clinical Global Impressions (CGI) (Guy, 1976) will be implemented at pre and post treatment by a blind evaluator to the treatment received. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life measured by SF 36 and social adjustment measured by EAS. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Group Cognitive Behavior Therapy
Behavioral: Group Cognitive Behavior Therapy
Structured protocol described by Cordioli et al., 2003
2: Active Comparator
Selective Serotonin Reuptake Inhibitor
Drug: SSRI (fluoxetine, sertraline, paroxetine, citalopram)
Fluoxetine (80mg/day or maximum tolerated dosage) Sertraline (200mg/day or maximum tolerated dosage) Paroxetine (60 mg/day or maximum tolerated dosage) Citalopram (60 mg/day or maximum tolerated dosage)

Detailed Description:

During the last decades, different pharmacological and psychotherapeutic strategies have been used to treat patients with obsessive compulsive disorder (OCD). Drugs that inhibit the serotonin recapture and the cognitive behavior therapy, that includes the exposition with response prevention and cognitive strategies, have been the most efficient treatment so far. This study's aims are to compare group cognitive-behavior therapy and standard pharmacological treatment (SRIs) in a world real population, using broader inclusion criteria. DSM-IV diagnostic criteria for OCD will be used (APA, 1994) and patients will be interviewed with the following instruments: SCID-I and Y-BOCS. Inclusion criteria are: (1) OCD diagnosis, (2) YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions), (3) informed consent to participate in this clinical trial. Exclusion criteria are: (1) patients with clinical or neurological diseases that may be worsen by the medications included in treatment protocol, (2) Current substance dependence, (3) Current psychotic symptoms, (4) Current suicide risk. Patients will be randomized in blocks of 12 and with stratification for the following parameters: current SSRI, age, sex and previous response to treatment. Rates of improvement will be based on the results of the YBOCS scores for obsessions and compulsions and on the results of the clinical global impression scale. Pos-treatment measures will be assessed by psychiatrists or psychologists not involved in the patients treatment that will be blind for the treatment being received by the patient. The patient will be considered responsive to treatment when he or she presents a reduction in YBOCS score ≥ 35% of the inicial score and a CGI score of 1 (very much improved) or 2 (much improved). The results of this study will help us to identify better health politics planning to a heterogeneous OCD population. So, it will improve our knowledge about the efficacy of the first line treatments in a real world OCD population.

  Eligibility

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

Inclusion Criteria:

  • Having been diagnosed with primary OCD according to the criteria set forth in the DSM-IV;
  • Current symptoms causing significant distress (YBOCS score greater than 16);
  • Not receiving current adequate treatment;
  • Accepting to participate in the study

Exclusion Criteria:

  • Having a clinical or neurological disease that might be worsened by the medicines included in the treatment protocol;
  • Presenting current substance dependence or abuse;
  • Exhibiting current psychotic symptoms; being currently at risk for suicide;
  • And, being pregnant or having the intention to become pregnant prior to the end of the treatment protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680602

Contacts
Contact: Cristina B Silva, Psychologist 5511 30696972 cristina.belotto@gmail.com
Contact: Izabel Pimentel, Nurse 5511 30696972 ext 169 izacprotoc@gmail.com

Locations
Brazil, SP
Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School Recruiting
São Paulo, SP, Brazil, 05403-010
Contact: Cristina B Silva, Psychologist     5511 30696972     cristina.belotto@gmail.com    
Contact: Izabel Pimentel, Nurse     5511 30696972 ext 169     izacprotoc@gmail.com    
Principal Investigator: Cristina B Silva, Psychologist            
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Cristina B Silva, Psychologist University of São Paulo
  More Information

Main site website  This link exits the ClinicalTrials.gov site

Responsible Party: Department & Institute of Psychiatry, Clinical Hospital, University of São Paulo ( Cristina Belotto da Silva )
Study ID Numbers: 06/50829-8
Study First Received: May 15, 2008
Last Updated: May 19, 2008
ClinicalTrials.gov Identifier: NCT00680602  
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
behavior therapy
group therapy
psychopharmacology

Study placed in the following topic categories:
Fluoxetine
Anxiety Disorders
Mental Disorders
Sertraline
Dexetimide
Paroxetine
Citalopram
Serotonin
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009