Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 40
- 主要终点
- Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder.
ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Study doctors put participants in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 adult participants with bipolar I or II disorder will be enrolled in approximately 40 sites worldwide.
Participants will receive oral capsules of ABBV-932 or matching placebo once daily for 6 weeks. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI), with a current depressive episode of at least 4 weeks and not exceeding 12 months.
- •Have a minimum score of 20 on the 17-item Hamilton Depression Rating Scale (HAMD-17).
- •Have a minimum score of 2 on Item 1 of the HAMD-17 at screening.
排除标准
- •Positive urine drug screen (UDS) result at screening.
- •Treated with any investigational drug within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug, is currently enrolled in another clinical study, or was previously enrolled in this study.
- •Current use of any antipsychotic, antidepressant, anticonvulsant, mood stabilizer, herb, or over-the-counter medication with psychoactive potential within 1 week or 5 half-lives of the medication (whichever is longer).
- •Prior exposure to ABBV-932 within 90 days prior to baseline.
研究组 & 干预措施
ABBV-932 Dose A
Participants will receive ABBV-932 Dose A.
干预措施: ABBV-932 (Drug)
ABBV-932 Dose B
Participants will receive ABBV-932 Dose B.
干预措施: ABBV-932 (Drug)
ABBV-932 Dose C
Participants will receive ABBV-932 Dose C.
干预措施: ABBV-932 (Drug)
Placebo for ABBV-932
Participants will receive placebo.
干预措施: Placebo for ABBV-932 (Drug)
结局指标
主要结局
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
时间窗: Up to Week 6
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
次要结局
- Change From Baseline in Clinical Global Impression-Severity - Bipolar Disorder (CGI-S-BP)(Up to Week 6)
- Change From Baseline in Functioning Assessment Short Test (FAST) Total Score(Up to Week 6)
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score(Up to Week 6)