A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change in depression as measured by the Quick Inventory of Depressive Symptoms (QIDS-C16)
研究概览
简要总结
The overall goal of this investigator-initiated trial is to evaluate the treatment outcome of depression utilizing platform algorithm products that can allow rapid identification of pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation. 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 depressed patients (SCID confirmed major depressive disorder or bipolar I/II disorder) to the Mayo Clinic Depression Center will be invited to participate in this study evaluating the Assurex GeneSight® platform; this new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, antipsychotic, and stimulant associated treatment outcomes for depression. This study will recruit treatment seeking patients with major depression with an index episode of moderate symptom severity that has been unresponsive or poorly tolerated to at least one prior antidepressant treatment. This will be an 8-week, double-blind trial where depressed patients are randomized to testing results of GeneSight® (tricolored clinical report) prior to treatment selection (n=138) vs. treatment as usual (tricolored dummy report) (n=138). All testing results will be made available after the 8-week trial.
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)
盲法说明
Subject and study staff will be blind to randomization.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65, male or female, any race/ethnicity
- •Mayo Clinic Depression Center inpatient or outpatient, or an outpatient of Mayo Clinic Rochester and satellite clinics, and outpatients from Mayo Clinic Health System clinics
- •Ability to provide informed consent
- •Structured Clinical Interview (SCID) confirmed major depressive episode associated with Major Depressive Disorder, Bipolar I/II disorder, or Schizoaffective Bipolar Disorder
- •Current index episode of major depression < 2 years duration
- •Moderate symptom severity defined by HAMD-17 rating scale score ≥ 17 [8]
- •Current index episode having not been treated with psychotropic medications or inadequately responsive to treatment (IRT). IRT defined as intolerability, adverse event, or inadequate efficacy of current psychotropic medication (at least 4 weeks duration)
- •Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests
- •Negative serum or urine pregnancy test (or history of hysterectomy)
- •Negative urine toxicology test (will only be completed at the request of the treating clinician).
排除标准
- •Inability to speak English
- •Inability or lack of willingness to provide informed consent
- •Axis I or II disorder other than depression (i.e., by clinical assessment) that is the primary reason for treatment
- •Psychotropic medication change (including dosage) between screening & baseline visit with exception of no more than 8mg of Ativan within a 24-hour period.
- •Patients who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for any significant current substance use disorder other than nicotine or caffeine. Must have at least early, partial or full, remission X 3 months
- •Clinically diagnosed cannabis use disorder, or SCID confirmed cannabis abuse or dependence.
- •Current clinical diagnosis delirium, dementia, other cognitive disorders, or non-mood psychotic disorder (i.e., schizophrenia, delusional disorder)
- •Index episode symptoms of hallucinations or delusions
- •Serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator
- •History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 6 months
- •Significant unstable medical condition
- •Hepatic insufficiency (2.5 X upper limit of normal (ULN) for Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ), past liver transplant recipient, and/or clinical diagnosis of cirrhosis of the liver
- •Malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications
- •Participation in another clinical trial within 30 days of the screening visit
- •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
- •Known cytochrome (CYP) & serotonin transporter genomic testing results within 5 years
- •A score of ≥15 on the Young Mania Rating Scale (YMRS)
研究组 & 干预措施
GeneSight guided treatment
GeneSight guided group will have their research psychiatrist make treatment recommendations based on AssureRx GeneSight genotyping results.
干预措施: AssureRx GeneSight genotyping results (Other)
Treatment as usual group
Treatment as usual group will have treatment recommendations based on clinical judgment
干预措施: Treatment as usual (Other)
结局指标
主要结局
Change in depression as measured by the Quick Inventory of Depressive Symptoms (QIDS-C16)
时间窗: baseline, 8 weeks
The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores \>/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.
次要结局
- Number of subjects with improvement of depressive symptoms as shown by a score <6 on QIDS-C16(8 weeks)
- Number of subjects with improvement of depressive symptoms as shown by 50% reduction in QIDS-C16 score(8 weeks)
- Improvement of depressive symptoms as shown by the Hamilton Rating Scale for Depression (HAMD-17)(8 weeks)
- Improvement of depressive symptoms(8 weeks)
- Number of subjects with improvement of depressive symptoms as shown by score of "much" or "very much improved" on Clinical Global Impression - Improvement Scale(8 weeks)
研究者
Mark Frye
Chair-Psychiatry/Psychology
Mayo Clinic