An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 871
- 试验地点
- 431
- 主要终点
- Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)
研究概览
简要总结
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transferred-entry participants:
- •Participants must have completed the double blind (DB) (expand DB) Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 without early treatment discontinuation or switch in the oral selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in the parent study
- •Direct-entry participants:
- •Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
- •Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire [MGH ATRQ]) and duration (at least 6 weeks) in the current episode of depression
- •Must be an outpatient at open-label treatment phase baseline
- •Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT)
- •Direct-entry and Transferred-entry Participants:
- •Participants should not take any prohibited medication or food supplements
排除标准
- •Transferred-entry Participants:
- •Participant has been non-compliant with the study intervention administration in the DB Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002 (that is, have missed either 4 or more consecutive doses of study intervention or a total of 8 or more doses during the DB Treatment Phase)
- •Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments
- •Direct-entry Participants:
- •Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
- •Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
- •Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients
研究组 & 干预措施
Aticaprant 10 mg
Participants will enter this study directly or after completing double-blind phase of studies 67953964MDD3001 or 67953964MDD3002 and will receive Aticaprant 10 milligrams (mg), once daily, orally in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy on Day 1 up to 52 weeks.
干预措施: Aticaprant (Drug)
结局指标
主要结局
Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)
时间窗: Up to Week 54
Withdrawal symptoms are assessed using the PWC-20. The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms.
Number of Participants with Adverse Events (AEs)
时间窗: Up to Week 54
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Number of Participants with Abnormal Body Mass Index (BMI)
时间窗: Up to Week 54
A BMI between 18.5 and 25 kilogram per meter square (kg/m\^2) indicates a normal weight.
Number of Participants with Abnormalities in Clinical Laboratory parameters
时间窗: Up to Week 54
Number of participants with abnormalities in clinical laboratory parameters will be reported.
Number of participants with Clinically Relevant Sexual Dysfunction Over Time as Measured by the Arizona Sexual Experiences Scale (ASEX) Score
时间窗: Up to Week 54
The ASEX is a participant-reported five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point scale, ranging from 1 to 6. Total score ranges from 5 to 30, with the higher scores indicating more sexual dysfunction.
Number of Participants with Adverse Events of Special Interest (AESI)
时间窗: Up to Week 54
AEs considered to be of special interest are as Pruritus and Diarrhea.
Number of Participants with Abnormal Body Weight
时间窗: Up to Week 54
Participants will be weighed at approximately the same time of day on the same scale, wearing lightweight clothing without shoes; they will be instructed to empty their bladders before being weighed.
Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: Up to Week 54
C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. The maximum score assigned for each participant will also be summarized into one of three categories: no suicidal ideation or behavior (0), suicidal ideation (1-5), suicidal behavior (6-10). Total score ranges from 1 to 10. Higher scores indicate greater severity.
Number of Participants with Change from Baseline in Vital Signs Abnormalities
时间窗: Up to Week 54
Vital signs include body weight, temperature, pulse/heart rate, respiratory rate, pulse oximetry and blood pressure (systolic and diastolic) values.
Number of Participants with Abnormalities in Electrocardiogram (ECG)
时间窗: Up to Week 54
Number of participants with abnormalities in ECG will be reported.
次要结局
- Change from Baseline in the Montgomery-asberg Depression Rating Scale (MADRS) Total Score Over Time(Baseline up to Week 54)
- Change from Baseline in the Participant Health Questionnaire, 9-Item (PHQ-9) Total Score over Time(Baseline up to Week 54)
- Change from Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score Over Time(Baseline up to Week 54)
- Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Total Score Over Time(Baseline up to Week 54)
- Percentage of Participants with Greater than or Equal to (>=) 50 percent (%) Reduction from Baseline in the MADRS Total Score Over Time(Week 54)
- Percentage of Participants with Remission of Depressive Symptoms Over Time(Week 54)