A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression (Abbreviation Assurex AMOD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 179
- 试验地点
- 4
- 主要终点
- Baseline to endpoint change in depression
研究概览
简要总结
The overall goal of this investigator-initiated trial is to evaluate the impact of platform algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation on treatment outcome of depression in adolescents. This new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence
详细描述
Treatment seeking adolescent patients with a moderate to severe major depressive episode defined as a 40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R) will be invited to participate in this study evaluating the GeneSight® platform. This new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, anti-psychotic, and stimulant treatment selection. These patients will have GeneSight® testing and will be randomized to one of two groups. In Group 1 (n=138), GeneSight® testing results will be available to the patient's treating clinician prior to treatment selection. In Group 2 (n=138), testing results will not be available to the patient's research treating clinician. However, all testing results will be made available to all participants and clinicians after the 8-week trial (upon completion of blinded assessments at week 8). The patients and the clinical raters will be blinded to group assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-18, male or female, any race/ethnicity
- •Treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.
- •Major depressive episode diagnosis or bipolar disorder based on KSADS-PL semi-structured psychiatric interview with a severity criteria-40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R)
- •Ability to provide informed consent
排除标准
- •Inability to speak English
- •Inability or lack of willingness to provide informed consent and assent.
- •Axis I diagnoses: Autism Spectrum Disorder, Anorexia Nervosa, Schizophreniform, and Schizophrenia.
- •Psychotropic medication change (including dosage) between screening & randomization visits.
- •Patients who meet DSM 5 criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. Must have at least early, partial or full, remission X 3 months
- •Serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator.
- •Significant unstable medical condition.
- •Anticipated inability to attend scheduled study visits.
- •Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol.
- •Cytochrome (CYP) & serotonin transporter genomic testing within 5 years.
结局指标
主要结局
Baseline to endpoint change in depression
时间窗: 8 weeks
The primary outcome measure is the baseline to endpoint change in the Children's Depression Rating Scale, Revised (CDRS-R).
次要结局
- Improvement of depressive symptoms(8 weeks)
研究者
Paul E. Croarkin
Paul E. Croarkin, D.O., M.S.
Mayo Clinic