Official Title: “Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Randomized Open Trial for Any Patient.”

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.

Study Type: Interventional

Study Design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2008

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.

Intervention(s) in this Clinical Trial

• Behavioral: Group Cognitive Behavior Therapy
  • Structured protocol described by Cordioli et al., 2003
• 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)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Group Cognitive Behavior Therapy
• Active Comparator: 2
  • Selective Serotonin Reuptake Inhibitor

Primary 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
    Safety Issue?: No

Secondary Measures

• Quality of life measured by SF 36 and social adjustment measured by EAS.
  • Time Frame: 12 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Sao Paulo

Overall Clinical Trial Officials and Contacts

Cristina B Silva, Psychologist Principal Investigator University of São Paulo  

Overall Contact: Cristina B Silva, Psychologist 5511 30696972 cristina.belotto@gmail.com

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00680602

Study ID Number: 06/50829-8

ClinicalTrials.gov Identifier: NCT00680602

Health Authority: Brazil: National Committee of Ethics in Research

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