2024-520333-68-00招募中3 期
A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 18
- 主要终点
- Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
To evaluate the efficacy of milsaperidone as an adjunctive treatment to antidepressant therapy for patients with Major Depressive Disorder (MDD) as measured by change from baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-5-TR criteria for MDD as confirmed by the Investigator and/or Sponsor-approved interviewer/rater via both: the Structural Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT), updated for DSM-5-TR, and review of the patient’s medical records/history (pharmacy records and/or a phone call with the patient’s physician is acceptable in lieu of medical records), or, if lacking adequate records, written approval from the Sponsor or Sponsor’s Designee;
- •The start of the current major depressive episode (MDE) is at least 8 weeks but no more than 24 months prior to screening;
- •Rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
- •CGI-S – Severity of Illness score of ≥ 4 at Screening and Baseline;
- •Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;
- •Currently having an inadequate response to antidepressant therapy (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 prior to the Screening Visit: bupropion, citalopram, duloxetine, escitalopram, fluoxetine, levomilnacipran (if locally approved for MDD), milnacipran (if locally approved for MDD), paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, vortioxetine
排除标准
- •Within the patient's lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD, including: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder; Bipolar Disorder;
- •Diagnosis of any current (within 6 months) psychiatric diagnosis other than MDD that has been confirmed by DSM-5-TR and that is a primary diagnosis 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; Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;
- •Experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;
- •Experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
- •In the opinion of the Investigator, has a significant risk for suicidal behavior during participation in the study or is considered to be in imminent danger to themselves or others. Any of the following categorically exclude a patient from participation: 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; or at Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts).
- •Has a first MDE at age 60 years or older.
结局指标
主要结局
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
次要结局
未报告次要终点
研究者
Vanda Pharmaceuticals
Scientific
Vanda Pharmaceuticals Netherlands B.V.
研究点 (18)
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