EUCTR2021-001192-17-BG进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 470
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Main Inclusion Criteria
- •1. Provides written informed consent;
- •2. Male or female patients between the ages of 18 and 65 years, inclusive;
- •3. 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.
- •4. 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
- •All Inclusion Criteria are presented in Section 6.3.1. of the enclosed protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 465
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Main Exclusion Criteria
- •Patients who meet any of the following exclusion criteria will not be able to participate in the study:
- •1. 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;
- •2. 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. Personality disorder of sufficient severity to have a major impact on the patient’s psychiatric status;
- •e. Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment;
- •3. The patient experiences a = 25% decrease in the MADRS total score between Screening (Visit 1) and Baseline (Visit 2);
- •4. The patient experiences a = 25% decrease in the QIDS-SR-16 total score between Screening (Visit 1) and Baseline (Visit 2);
- •5. 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. At Screening (Visit 1) or Baseline (Visit 2), the patient scores = 5 on MADRS Item 10 (Suicidal Thoughts), or
- •d. The patient is considered to be in imminent danger to him/herself or others.
- •6. The patient has a first MDE at age 60 years or older. All Exclusion Criteria are presented in Section 6.3.2. of the enclosed protocol
研究者
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