Daniel Fatori1, Carlos Alberto de Bragança Pereira2, Fernando R Asbahr3, Guaraci Requena2, Pedro G Alvarenga3, Maria Alice de Mathis3, Luis A Rohde4, James F Leckman5, John S March6, Guilherme V Polanczyk7, Eurípedes C Miguel7, Roseli G Shavitt7. 1. Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil; National Institute of Developmental Psychiatry for Children and Adolescents (INCT-CNPq), São Paulo, Brazil. Electronic address: daniel.fatori@usp.com. 2. Institute of Mathematics and Statistics, University of Sao Paulo, Sao Paulo, Brazil. 3. Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil. 4. Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil; National Institute of Developmental Psychiatry for Children and Adolescents (INCT-CNPq), São Paulo, Brazil; Department of Psychiatry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil. 5. Child Study Center, School of Medicine, Yale University, New Haven, CT, USA. 6. Division of Neurosciences Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA. 7. Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil; National Institute of Developmental Psychiatry for Children and Adolescents (INCT-CNPq), São Paulo, Brazil.
Abstract
OBJECTIVE: This sequential multiple assignment randomized trial (SMART) tested the effect of beginning treatment of childhood OCD with fluoxetine (FLX) or group cognitive-behavioral therapy (GCBT) accounting for treatment failures over time. METHODS: A two-stage, 28-week SMART was conducted with 83 children and adolescents with OCD. Participants were randomly allocated to GCBT or FLX for 14 weeks. Responders to the initial treatment remained in the same regimen for additional 14 weeks. Non-responders, defined by less than 50% reduction in baseline Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores, were re-randomized to either switch to or add the other treatment. Assessments were performed at baseline, 7, 14, 21, and 28 weeks. RESULTS: Among the 43 children randomized to FLX who completed the first stage, 15 (41.7%) responded to treatment and 21 non-responders were randomized to switch to (N = 9) or add GCBT (N = 12). Among the 40 children randomized to GCBT who completed the first stage, 18 (51.4%) responded to treatment and 17 non-responders were randomized to switch to (N = 9) or add FLX (N = 8). Primary analysis showed that significant improvement occurred in children initially treated with either FLX or GCBT. Each time point was statistically significant, showing a linear trend of symptom reduction. Effect sizes were large within (0.76-0.78) and small between (-0.05) groups. CONCLUSIONS:Fluoxetine and GCBT are similarly effective initial treatments for childhood OCD considering treatment failures over time. Consequently, provision of treatment for childhood OCD could be tailored according to the availability of local resources.
RCT Entities:
OBJECTIVE: This sequential multiple assignment randomized trial (SMART) tested the effect of beginning treatment of childhood OCD with fluoxetine (FLX) or group cognitive-behavioral therapy (GCBT) accounting for treatment failures over time. METHODS: A two-stage, 28-week SMART was conducted with 83 children and adolescents with OCD. Participants were randomly allocated to GCBT or FLX for 14 weeks. Responders to the initial treatment remained in the same regimen for additional 14 weeks. Non-responders, defined by less than 50% reduction in baseline Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores, were re-randomized to either switch to or add the other treatment. Assessments were performed at baseline, 7, 14, 21, and 28 weeks. RESULTS: Among the 43 children randomized to FLX who completed the first stage, 15 (41.7%) responded to treatment and 21 non-responders were randomized to switch to (N = 9) or add GCBT (N = 12). Among the 40 children randomized to GCBT who completed the first stage, 18 (51.4%) responded to treatment and 17 non-responders were randomized to switch to (N = 9) or add FLX (N = 8). Primary analysis showed that significant improvement occurred in children initially treated with either FLX or GCBT. Each time point was statistically significant, showing a linear trend of symptom reduction. Effect sizes were large within (0.76-0.78) and small between (-0.05) groups. CONCLUSIONS:Fluoxetine and GCBT are similarly effective initial treatments for childhood OCD considering treatment failures over time. Consequently, provision of treatment for childhood OCD could be tailored according to the availability of local resources.
Authors: Edoardo F Q Vattimo; Vivian B Barros; Guaraci Requena; João R Sato; Daniel Fatori; Euripedes C Miguel; Roseli G Shavitt; Marcelo Q Hoexter; Marcelo C Batistuzzo Journal: Eur Child Adolesc Psychiatry Date: 2019-04-10 Impact factor: 4.785
Authors: Cristiane F Bortoncello; Nicolas de Oliveira Cardoso; Eduarda Z Salvador; Richard C de Avila; Wagner de L Machado; Ygor A Ferrão Journal: Braz J Psychiatry Date: 2022-06-23