CTRI/2023/04/051968招募中3 期
A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 470
- 试验地点
- 20
- 主要终点
- •To evaluate the efficacy of lumateperone 42 mg administered once daily compared with placebo as adjunctive treatment to antidepressant therapy in patients with Major Depressive Disorder (MDD) who have an inadequate response to ongoing antidepressant therapy (ADT) as measured by change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
研究概览
简要总结
This is an international, multicenter, randomized, double-blind, placebo controlled,
parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
The study will be conducted in three periods
• Screening Period (up to 2 weeks) during which patient eligibility will be assessed
• Double-blind Treatment Period (6 weeks) in which all patients will be randomized to receive placebo or lumateperone 42 mg/day in 1:1 ratio.
Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients will be eligible for study participation if they meet the following inclusion criteria:
- •Provides written informed consent
- •Male or female patients between the ages 18 and 65 years, inclusive
- •Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor approved rater using the MINI and meets all of the following criteria: a.
- •The start of the current major depressive episode (MDE) is at least 8 weeks but not more than 18 months prior to Screening (Visit 1) b.
- •Has at least moderate severity of illness based on rater administered MADRS total score ≥ 24 at Screening (Visit 1) and at Baseline (Visit 2) c.
- •Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening (Visit 1) and at Baseline (Visit 2) d.
- •Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening (Visit 1) and at Baseline (Visit 2) e.
- •Has sufficient history and medical record confirmation verifying the ADT and the current MDE is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning.
- •Currently having an inadequate response to ADT (less than 50% improvement) as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration: a.
- •citalopram/escitalopram b.
- •fluoxetine c.
- •paroxetine d.
- •sertraline e.
- •duloxetine f.
- •levomilnacipran/milnacipran (if locally approved for MDD) g.
- •venlafaxine/desvenlafaxine h.
- •bupropion i.
- •vilazodone j.
- •vortioxetine.
排除标准
- •Patients who meet any of the following exclusion criteria will not be able to participate in the study:
- •Within the patient’s lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including: a.
- •Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder b.
- •Bipolar disorder
- •Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including: a.
- •Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses.
- •Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment b.
- •Eating disorder c.
- •Substance use disorders (excluding nicotine) d.
- •Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
- •The patient experiences a ≥ 25% decrease in the MADRS total score between Screening (Visit 1) and Baseline (Visit 2)
- •The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening (Visit 1) and Baseline (Visit 2)
- •In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or: a.
- •At Screening (Visit 1), the patient scores “yes†on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline (Visit 2), the patient scores “yes†on Suicidal Ideation Items 4 or 5 since the Screening Visit b.
- •At Screening (Visit 1), the patient has had 1 or more suicide attempts within 2 years prior to Screening c.
- •The patient is considered to be in imminent danger to him/herself or others.
- •The patient has a first MDE at age 60 years or older.
结局指标
主要结局
•To evaluate the efficacy of lumateperone 42 mg administered once daily compared with placebo as adjunctive treatment to antidepressant therapy in patients with Major Depressive Disorder (MDD) who have an inadequate response to ongoing antidepressant therapy (ADT) as measured by change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
时间窗: From baseline to Day 43
次要结局
- •To evaluate the efficacy of lumateperone 42 mg administered once daily compared with placebo as adjunctive treatment to ADT in patients with MDD who have an inadequate response to ongoing ADT as measured by change from baseline to Day 43 in the Clinical Global Impression Scale-Severity (CGI-S).(From baseline to Day 43)
研究者
研究点 (20)
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