NCT05061706已完成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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Montgomery-Asberg Depression Rating Scale
研究概览
简要总结
This is a 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.
详细描述
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male or female patients between the ages of 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:
- •The start of the current major depressive episode (MDE) is at least 8 weeks but not more than 18 months prior to Screening;
- •Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
- •Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening (Visit 1) and at Baseline;
- •Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;
- •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 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:
- •citalopram/escitalopram
- •levomilnacipran/milnacipran (if locally approved for MDD)
- •venlafaxine/desvenlafaxine
- •vortioxetine
排除标准
- •Within the patient's lifetime, has a confirmed DSM-5 psychiatric diagnosis other than MDD, including:
- •Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
- •Bipolar Disorder;
- •Within 6 months of Screening, has a confirmed DSM-5 psychiatric diagnosis other than MDD including:
- •Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses.
- •Eating disorder;
- •Substance use disorders (excluding nicotine);
- •Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;
- •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 and Baseline;
- •The patient experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
- •In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during participation in the study or:
- •At Screening, 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, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;
- •At Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening;
- •At Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts), or
- •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.
研究组 & 干预措施
Lumateperone 42 mg
Experimental
干预措施: Lumateperone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale
时间窗: Day 43
Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
次要结局
- Clinical Global Impression Scale-Severity(Day 43)
研究者
研究点 (2)
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