Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in Weight (in Lbs.)
研究概览
简要总结
The purpose of this study is to get a better understanding of the side effect burden and identify predictors of psychotic, mood and aggressive disorders in children and adolescents. The study's primary aim is to identify genetic risk factors for weight gain and metabolic abnormalities.
详细描述
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAPs (second generation antipsychotics) during 4 visits over 12 weeks. Participants will also be evaluated at month 6, 9, and 12. This study does not involve treatment for participants. Treatment of subjects enrolled in this study will be determined by their clinician and will remain unaffected by participation in this observational minimal risk study.
All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25mg to 6mg daily for 52 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 3 and 19 (at the time of consent)
- •Clinical diagnosis of psychotic disorders (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified and prodromal schizophrenia (as defined by the Scale of Prodromal Symptoms (SOPS: Miller 1996)), mood disorder (i.e., bipolar disorder, major depressive disorder, depressive disorder not otherwise specified, mood disorder not otherwise specified) or an autism spectrum disorder.
- •Subjects who are considered for treatment with second generation antipsychotics (SGAPs) by a physician who has evaluated him/her
- •Subjects who are either A) antipsychotic naïve and have started an SGA within the past 2 weeks , B) have started a new antipsychotic within the past 2 weeks (specifically within 2 weeks of their first blood draw), or
排除标准
- •Individuals younger than 3 years or older than 19 years and 11 months (at the time of consent)
- •Personal history of or comorbid eating disorders
- •Active hyper-/hypothyroidism
- •Severe medical disorder (i.e., AIDS, cancer, sepsis, etc.).
结局指标
主要结局
Change in Weight (in Lbs.)
时间窗: Baseline and 52 Weeks
Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.
次要结局
- Change in Total Cholesterol (mg/dL)(Baseline and 52 Weeks)
- Change in Triglycerides (mg/dL)(Baseline and 52 Weeks)
- Change in LDL (mg/dL)(Baseline and 52 Weeks)
- Change in Glucose Levels (mg/dL)(Baseline and 52 Weeks)
研究者
Linmarie Sikich, MD
Associate Professor of Psychiatry
University of North Carolina, Chapel Hill