A Randomized, Placebo-Controlled, Double-Blinded, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Oral NORA520 in Female Adults With Severe Postpartum Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 33
- 主要终点
- Incidence, severity, and causality of AEs, SAEs, and AESIs
研究概览
简要总结
The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine:
- How well NORA520 is tolerated and what side effects it may cause
- If NORA520 reduces depressive symptoms in subjects with severe PPD
- The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken
- In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits
- •Are an adult female between 18 and 45 years of age, inclusive;
- •Have either ceased lactating at Screening, or if still lactating or actively breastfeeding at Screening, agree to temporarily cease giving breastmilk to their infant(s) from just prior to first dose of study drug on Day 1 through Day 14;
- •Have a negative pregnancy test at Screening and Day 1 (prior to dosing);
- •Have had a depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery
- •Are ≤9 months postpartum at Screening.
排除标准
- •Have a history or current diagnosis or current treatment of bipolar disorder, schizophrenia, or schizoaffective disorder;
- •Have had recorded treatment failure of ≥2 different antidepressant classes (e.g., SSRI, SNRI) in the current or previous episode;
- •Are currently experiencing active psychosis per Investigator assessment, or are taking typical or atypical antipsychotic medication;
- •Have a history of suicidal behavior within 2 years;
- •Have a history or current diagnosis of sleep apnea or narcolepsy.
研究组 & 干预措施
NORA520 Tablets Dose 1
NORA520 Tablets Dose 1
干预措施: NORA520 Dose 1 (Drug)
NORA520 Tablets Dose 2
NORA520 Tablets Dose 2
干预措施: NORA520 Dose 2 (Drug)
Placebo Tablets
Placebo Tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence, severity, and causality of AEs, SAEs, and AESIs
时间窗: Up to Day 30
Adverse events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Change from baseline in HAM-D17 total score compared to placebo
时间窗: Baseline to Day 4
The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, sexual interest, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
次要结局
- Change from baseline in HAM-D17 total score(Baseline to Days 8 and 30)
- Change from baseline in Clinical Global Impression - Severity (CGI-S) score(Baseline to Days 4, 8, and 30)
- Clinical Global Impression - Improvement (CGI-I) scale positive response(Baseline to Days 4, 8, and 30)
- HAM-D17 remission(Baseline to Days 4, 8, and 30)
- Change from baseline in HAM-D17 subscale and individual item scores(Baseline to Days 4, 8, and 30)
- Change from baseline in Edinburgh Postnatal Depression Scale (EPDS) total score(Baseline to Days 8 and 30)
- HAM-D17 response(Baseline to Days 4, 8, and 30)
- Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score(Baseline to Days 4, 8, and 30)
- Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score(Baseline to Days 4, 8, and 30)
- Number of patients who start any new antidepressant or anti-anxiety medication(After Day 8 assessments through Day 30)