Combinatorial Pharmacogenomics Testing in Treatment-Naïve Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Depression change score- Week 8
研究概览
简要总结
This study aims to determine whether the GeneSight Psychotropic test can result in better treatment outcomes for patients with treatment-naive major depressive disorder
详细描述
Major Depressive Disorder is a chronic psychiatric illness that leads to devastating consequences at the individual and societal levels. Today, the choice of treatment continues to be largely based on subjective factors, primarily the clinician and/or patient's preferences, as well as the individual's history of response to treatment, often tainted by recall bias. Psychiatric medication decisions are even more arbitrary when the subject in question has not had past treatment trials. This often leads to a trial and error process and an increasingly resistant disease with each failed trial. Early implementation of an objective tool designed for tailoring medication choice to an individual may prove highly beneficial in decreasing illness chronicity, individual suffering, and economic burden.
GeneSight Psychotropic test is a pharmacogenomic decision support tool, developed to help clinicians make informed, evidence-based decisions about proper drug selection. Therefore, we propose conducting a randomized, double blind, controlled trial to evaluate the impact of the GeneSight Psychotropic test to guide treatment decisions in patients with treatment-naïve (never having taken medication for depression) Major Depressive Disorder.
This study will involve 6 visits over about 24 weeks where participants will be randomized to have their study clinician have access to their pharmacogenetic report in order to make treatment decisions, or to not have access to their report for the first 12 weeks. At Visit 5, Week 12, all participants will receive a copy of their pharmacogenetics report and all clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Coordinators at site are blinded, Sponsor and associates are unblinded.
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
- •Adults 18-65 years of age
- •Treatment-naïve major depressive disorder meeting Diagnostic and Statistical Manual 4th Edition (DSM-IV) criteria, without psychosis
- •Total baseline score on the Quick Inventory Of Depressive Symptomatology Clinician-rated (QIDS-C16) and the Quick Inventory Of Depressive Symptomatology Self-Report (QIDS-SR16) rating scale ≥11
- •Good command of the English language
排除标准
- •Patients with a current diagnosis of schizophrenia
- •Patients with a current diagnosis of schizoaffective disorder
- •Patients with a current diagnosis of bipolar disorder (any type)
- •Currently meeting DSM-IV criteria for significant substance use disorder (exception: nicotine use disorder)
- •A diagnosis of personality disorder that may interfere with the patient's ability to improve on pharmacologic treatment, as determined by study investigator
- •Patients currently receiving electroconvulsive therapy(ECT), deep brain stimulation (DBS) or transcranial magnetic stimulation (TMS) treatment
- •History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months
- •Significant unstable medical condition; life threatening disease; hepatic insufficiency; liver transplant recipient; cirrhosis of the liver; need for therapies that may obscure the results of treatment and/or of the study; 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
- •History of gastric bypass surgery
- •Acute suicidal intention and/or in need of immediate hospitalization as judged by the investigator
- •Active psychotic symptoms
- •Currently in an inpatient facility
- •History of prior pharmacogenomic testing
- •Currently pregnant or lactating
- •Inability to provide informed consent
- •Any other factor that in the investigators' judgment may affect patient safety or compliance
研究组 & 干预措施
GeneSight Psychotropic test
Participants randomized to have their study clinician have access to their pharmacogenetic report (provided through the GeneSight Psychotropic tool) in order to make treatment decisions for the first 12 weeks. At Visit 5, Week 12, participants will receive a copy of their pharmacogenetics report and clinicians will continue to be able to use the results to guide treatment options for an additional 12 weeks.
干预措施: GeneSight Psychotropic test (Other)
GeneSight Psychotropic test
Participants randomized to have their study clinician have access to their pharmacogenetic report (provided through the GeneSight Psychotropic tool) in order to make treatment decisions for the first 12 weeks. At Visit 5, Week 12, participants will receive a copy of their pharmacogenetics report and clinicians will continue to be able to use the results to guide treatment options for an additional 12 weeks.
干预措施: FDA-approved antidepressant or antipsychotic treatment (Drug)
Treatment As Usual
Participants randomized to treatment as usual will receive treatment from study clinicians who do not have access to the participant's report for the first 12 weeks. At Visit 5, Week 12, participants will receive a copy of their pharmacogenetics report and clinicians will be unblinded to be able to use the results to guide treatment options for an additional 12 weeks.
干预措施: FDA-approved antidepressant or antipsychotic treatment (Drug)
结局指标
主要结局
Hamilton Rating Scale for Depression change score- Week 8
时间窗: Baseline to Week 8
17-item Hamilton Rating Scale for Depression (HAM-D17) to assess mean change in depressive symptoms severity. Total range of the Hamilton Rating Scale for Depression is 0 to 52, with a greater score being an indication of more severe depressive symptoms.
次要结局
- Hamilton Rating Scale for Depression change score- Week 24(Baseline to end of week 24)
- Hamilton Rating Scale for Depression change score- Week 12(Baseline to end of week 12)
- Hamilton Rating Scale for Depression change score- Week 4(Baseline to end of week 4)