Group Cognitive Behavioral Therapy Versus Fluoxetine for Obsessive-Compulsive Disorder: a Practical Trial
GCBTVF
1 other identifier
interventional
158
1 country
1
Brief Summary
First line treatments fo Obsessive Compulsive Disorder (OCD) are Selective Serotonin Recapture 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 GCBT and 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 15, 2008
CompletedFirst Posted
Study publicly available on registry
May 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFebruary 16, 2009
February 1, 2009
2.7 years
May 15, 2008
February 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Secondary Outcomes (1)
Quality of life measured by SF 36 and social adjustment measured by EAS.
12 weeks
Study Arms (2)
1
EXPERIMENTALGroup Cognitive Behavior Therapy
2
ACTIVE COMPARATORSelective Serotonin Reuptake Inhibitor
Interventions
Structured protocol described by Cordioli et al., 2003
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School
São Paulo, São Paulo, 05403-010, Brazil
Related Publications (4)
da Conceicao Costa DL, Shavitt RG, Castro Cesar RC, Joaquim MA, Borcato S, Valerio C, Miguel EC, Diniz JB. Can early improvement be an indicator of treatment response in obsessive-compulsive disorder? Implications for early-treatment decision-making. J Psychiatr Res. 2013 Nov;47(11):1700-7. doi: 10.1016/j.jpsychires.2013.07.006. Epub 2013 Aug 13.
PMID: 23948637DERIVEDHoexter MQ, Dougherty DD, Shavitt RG, D'Alcante CC, Duran FL, Lopes AC, Diniz JB, Batistuzzo MC, Evans KC, Bressan RA, Busatto GF, Miguel EC. Differential prefrontal gray matter correlates of treatment response to fluoxetine or cognitive-behavioral therapy in obsessive-compulsive disorder. Eur Neuropsychopharmacol. 2013 Jul;23(7):569-80. doi: 10.1016/j.euroneuro.2012.06.014. Epub 2012 Jul 27.
PMID: 22841131DERIVEDBelotto-Silva C, Diniz JB, Malavazzi DM, Valerio C, Fossaluza V, Borcato S, Seixas AA, Morelli D, Miguel EC, Shavitt RG. Group cognitive-behavioral therapy versus selective serotonin reuptake inhibitors for obsessive-compulsive disorder: a practical clinical trial. J Anxiety Disord. 2012 Jan;26(1):25-31. doi: 10.1016/j.janxdis.2011.08.008. Epub 2011 Aug 19.
PMID: 21907540DERIVEDFossaluza 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. doi: 10.1590/s1807-59322009000600005.
PMID: 19578654DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cristina B Silva, Psychologist
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 15, 2008
First Posted
May 20, 2008
Study Start
January 1, 2006
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
February 16, 2009
Record last verified: 2009-02