Adaptive Treatment Strategies for Children and Adolescents With Psychiatric Disorders in the Context of Public Health: "Medicine in Practice"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Treatment response status at week 28
研究概览
简要总结
Obsessive-compulsive disorder affects approximately 2% of the population, frequently has its onset during childhood or adolescence and is potentially incapacitating. If not properly treated, this disorder tends to follow a chronic course. Pharmacotherapy with clomipramine and selective serotonin reuptake inhibitors (SSRIs), such as fluvoxamine, fluoxetine and sertraline, has been approved for pediatric OCD. However, up to 30% of patients may not benefit from these treatments, and the presence of residual symptoms is frequent among treatment responders. Cognitive-behavioral therapy (CBT) is also recognized as first line treatment for pediatric OCD, either administered in individual or group format. There is evidence suggesting equivalent efficacy for SSRIs and CBT in pediatric OCD, but there is no data on adaptive treatment strategies regarding such treatments on the long term outcome of OCD patients. The aim of this study is to verify, in a randomized design, if there is an optimal sequential treatment strategy for pediatric OCD, adopting the two most studied treatments for this disorder: an SSRI and group CBT (GCBT). The investigators hypotheses are: (1) both types of treatment will present similar efficacy in the short term (14 weeks); (2) for non-responders to the first type of treatment (fluoxetine up to 80mg/day or GCBT for 14 weeks), combined treatment (fluoxetine + GCBT for another 14 weeks) will be more effective than switching treatment modality (from fluoxetine to GCBT or from GCBT to fluoxetine for additional 14 weeks) after additional 14 weeks.
详细描述
This is a 28-week open protocol, composed of two phases of randomized treatments with 14 weeks duration.
Inclusion criteria: DSM-IV diagnosis of OCD; age between 7 and 17 years; willing to participate in the protocol; parents or legal tutors agreement with their child participation in the protocol; absence of physical or cognitive impairment that prevent the participation in the protocol.
We expect to end the protocol with 50 patients in each arm (total = 200). For this reason, the purpose is to recruit at least 400 patients for the first randomization (R1: fluoxetine X group CBT). Responders to the initial type of treatment will be maintained in the same procedure for additional 14 weeks. The second randomization (R2) will address non-responders to fluoxetine, who will be randomized to switch to group CBT or receive group CBT as add-on therapy; and non-responders to group CBT, who will be randomized to switch to fluoxetine or receive fluoxetine as add-on therapy.
Fluoxetine will be administered in drops or capsules, in doses ranging from 10 to 80mg/day. Group CBT will be delivered weekly, in 2-hour sessions, in groups of 6 to 8 participants.
At the end of each treatment (weeks 14 and 28), treatment response will be assessed by blind raters, through the YBOCS and CGI-global improvement subscale. Response will be defined as at least 35% reduction in baseline YBOCS scores and a CGI score of 1 or 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of obsessive-compulsive disorder according to DSM-IV as major problem
- •7 to 17 years
- •who agree to participate in the research
- •who have parental permission or legal guardian to participate in the research
- •that do not have physical or cognitive impairments that prevent the participation of research
- •YBOCS ≥ 16 for obsession and compulsion or ≥ 10 for only obsession or compulsion only
- •Be above the tenth percentile of weight corresponding to age
- •IQ greater than 80 - assessed using the Raven (the screening, if necessary)
排除标准
- •Inability to study evaluated adherence to the beginning.
- •ANY medical or neurological condition that determines contraindication to any of the treatments or that may influence the evaluation protocol
- •pregnancy (women of childbearing age should use contraception)
- •Suicidal ideation (with intent) CURRENT
研究组 & 干预措施
Fluoxetine
drops or capsules, 10 to 80mg/Day for 14 weeks (first treatment) and as add-on to group CBT non-responders for additional 14 weeks
干预措施: fluoxetine (Drug)
Group cognitive-behavioral therapy
weekly, 2 hour sessions with one therapist and one co-therapist for 14 weeks and as add-on to fluoxetine non-responders for additional 14 weeks
干预措施: Group cognitive-behavioral therapy (Behavioral)
结局指标
主要结局
Treatment response status at week 28
时间窗: Yale-Brown Obsessive-Compulsive Scale scores at week 28
The primary outcome will be the treatment response status, as measured by the variation of Yale-Brown Obsessive-Compulsive Scale,after having received,in a randomized design, different sequential treatments for obsessive-compulsive disorder.
Treatment response status at week 14
时间窗: Yale-Brown Obsessive Compulsive Scale Score at week 14
Treatment resposnse to the first treatment assigned, fluoxetine or group cognitive-behavioral therapy, will be assessed at week 14. Non- responders will be randomized to the second treatment: either combination therapy (fluoxetine plus group cognitive-behavioral therapy) or switch to the other first line treatment (non-responders to fluoxetine as the first treatment switch to group cognitive behavioral therapy and non-responders to cognitive behavioral therapy switch to fluoxetine)
次要结局
- Predictors of treatment response at week 28(KID-SADS, Family Accomodation Scale, Dimensional Yael-Brown Obsessive-Compulsive Scale)
研究者
Roseli Shavitt
MD, PhD
University of Sao Paulo