NCT05850689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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 470
- 试验地点
- 72
- 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 modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and meets all of the following criteria:
- •The start of the current major depressive episode (MDE) is at least 12 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 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 (less than 50% improvement) to 2 or more ADTs in the current MDE 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:
- •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. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment;
- •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
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 (72)
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