12 Week, Randomized, Double-Blind, Controlled Evaluation Followed by an Open Label 12-Week Follow-up Period of the Impact of GeneSight Psychotropic on Response to Psychotropic Treatment in Outpatients Suffering From A Major Depressive Disorder (MDD) Having Had- Within the Current Episode- An Inadequate Response to at Least One Medication Included in GeneSight Psychotropic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,398
- 试验地点
- 116
- 主要终点
- Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks
研究概览
简要总结
Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 8 of the study.
详细描述
Major depressive disorder (MDD) is a highly prevalent (Hasin et al., 2005) mental disorder and a leading source of disease burden worldwide (Lopez et al., 2006). Epidemiological studies estimate 12-month and lifetime prevalence for MDD in the United States to be 5.3% and 13.2%, respectively (reviewed in Blanco et al., 2010). MDD is expected to be the second greatest cause of disability by 2020 and has been shown to cause significant morbidity, affecting people's ability to work, function in relationships, and engage in social activities. Moreover, MDD increases the risk of suicidal ideation, attempted suicide, and death by completed suicide.
Prospective longitudinal studies of patient samples show that MDD is a chronic illness, characterized by remitting and recurrent depressive episodes (Solomon et al., 1997; Mueller et al., 1999). A major depressive episode is characterized by a low mood or an inability to experience pleasure (anhedonia), or both, for more than 2 weeks, combined with several cognitive and vegetative symptoms and the occurrence of distress or impairment (reviewed in Rot et al., 2009). In the US, nearly 1 in 5 people will experience a major depressive episode at some point in their lives (reviewed in Rot et al., 2009). Drugs currently available to treat depression fall into the categories of those that have their main effect by increasing norepinephrine (NE) (the tricyclic or tetracyclic antidepressants [TCAs]), those that increase serotonin (5-HT) (the selective serotonin reuptake inhibitors [SSRIs]), and those that increase both NE and 5-HT (the monoamine oxidase inhibitors [MAOIs] and the serotonin and norepinephrine reuptake inhibitors [SNRIs]). While all antidepressants achieve similar levels of efficacy, treatment failures are relatively high ranging from 30 to 60% (Simpson and DePaulo). Additionally, many of these compounds are associated with significant adverse events (AEs).
The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.
The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.
Tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated ICF will be obtained from each patient before participation in the study;
- •Have provided written authorization for the use and disclosure of their protected health information;
- •Be ≥18 years of age;
- •Suffer from a Major Depressive Episode meeting DSM-IV-TR criteria;
- •Have had an inadequate response within the current episode to at least 1 psychotropic treatment. Inadequate response is defined as inadequate efficacy after 6 weeks of a psychotropic treatment or discontinuation of a psychotropic treatment due to AEs or intolerability;
- •Have a total baseline score on the QIDS-C16 and QIDS-SR16 rating scale ≥11;
- •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.
排除标准
- •Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator;
- •Patients with a diagnosis of Bipolar I or II disorder;
- •Patients with a current Axis I diagnosis of:
- •Amnestic and other cognitive disorder
- •Schizophrenia or other psychotic disorder;
- •Patients having experienced hallucinations, delusions, or any psychotic symptomatology within the current depressive episode or during prior depressive episodes;
- •Patient is currently in an inpatient facility;
- •Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months;
- •Patients who meet DSM-IV-TR criteria for any significant current substance use disorder;
- •Patients with significant unstable medical condition; life threatening disease; hepatic insufficiency (3X ULN for AST and/or ALT); 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;
- •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;
- •Patients with a history of prior pharmacogenomic testing;
- •Any change in psychotropic medication (including change in dosage) between screening and randomization;
- •Patients receiving ECT, DBS or TMS treatment (should a Subject receive any of these treatments they must be discontinued from the study);
- •Patients who are known to be pregnant or lactating;
- •Patients with a history of gastric bypass surgery.
结局指标
主要结局
Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks
时间窗: from baseline to end of Week 8
Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean percent change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 8 of the study. Scores range from 0 to 50, and lower scores are better outcomes. Percent change is defined as (week 8 score -baseline score) / (baseline score) x 100.
次要结局
- Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks(from baseline to end of Week 8)
- Percentage of Responders at Week 8 for HAM-D17(Week 8 visit info)
- Percentage of Responders at Week 12 for HAM-D17(Week 12 visit info)
- Percentage of Remitters at Week 12 Defined as HAM-D17 ≤7(week 12 visit info)
- Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group;(week 8 visit info)
- Time to Response/Remission of Depressive Symptoms Over 8 Weeks;(week 4 and 8 visit info)
- Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks(Baseline to week 24 visits)
- Percentage of Responders at Week 8 for QIDS-C16(Week 8 visit info)
- Percentage of Responders at Week 8 for PHQ-9(Week 8 visit info)
- Percentage of Remitters at Week 12 Defined as QIDS-C16 ≤5(week 12 visit info)
- Percentage of Remitters at Week 12 Defined as PHQ-9 <5(week 12 visit info)
- Percentage of Remitters at Week 12 Defined as CGI-S ≤1(week 12 visit info)
- Percentage of Responders at Week 12 for QIDS-C16(Week 12 visit info)
- Percentage of Responders at Week 12 for PHQ-9(Week 12 visit info)
- Percentage of Responders at Week 12 for CGI-S(Week 12 visit info)
- Percentage of Responders at Week 12 for CGI-I(Week 12 visit info)
- Percentage of Responders at Week 12 for CGI-EI(Week 12 visit info)
- Percentage of Remitters at Week 8 Defined as QIDS-C16 ≤ 5 in Each Treatment Group(week 8 visit info)
- Percentage of Remitters at Week 8 Defined as PHQ-9 <5 in Each Treatment Group(week 8 visit info)
- Time to Response/Remission of Depressive Symptoms Over 12 Weeks;(week 4, 8, and 12 visit info)
- Percentage of Responders at Week 24 for HAM-D17 in the GeneSight Psychotropic Tested Treatment Group(Baseline to week 24 visit info)
- Percentage of Remitters at Week 24 Defined as HAM-D17 ≤7 in the GeneSight Psychotropic Tested Treatment Group(Baseline to week 24 visit info)