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Sponsors and Collaborators: |
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo |
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Information provided by: | University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00680602 |
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 |
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Obsessive Compulsive Disorder |
Behavioral: Group Cognitive Behavior Therapy Drug: SSRI (fluoxetine, sertraline, paroxetine, citalopram) |
Phase IV |
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. |
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 |
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1: Experimental
Group Cognitive Behavior Therapy
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Behavioral: Group Cognitive Behavior Therapy
Structured protocol described by Cordioli et al., 2003
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2: Active Comparator
Selective Serotonin Reuptake Inhibitor
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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)
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cristina B Silva, Psychologist | 5511 30696972 | cristina.belotto@gmail.com |
Contact: Izabel Pimentel, Nurse | 5511 30696972 ext 169 | izacprotoc@gmail.com |
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 |
Principal Investigator: | Cristina B Silva, Psychologist | University of São Paulo |
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 |
behavior therapy group therapy psychopharmacology |
Fluoxetine Anxiety Disorders Mental Disorders Sertraline Dexetimide |
Paroxetine Citalopram Serotonin Obsessive-Compulsive Disorder |
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 |