Multicenter, Open-label Study to Evaluate the Long-term 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
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 82
- 主要终点
- Number of Participants Experiencing Adverse Events
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. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated 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. Participants with bipolar I or II disorder who are currently experiencing a depressive episode will enter the study and be treated with open-label ABBV-932. Approximately 200 adult participants with bipolar I or II disorder will be enrolled in approximately 50 sites in the United States and Puerto Rico.
Participants will receive oral capsules of ABBV-932 for a 26-week treatment period. The treatment period will be followed by a safety follow-up (SFU) period of 30 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regularly scheduled 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
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) >= 18.0 to <= 40.0 kg/m^2, inclusive.
- •Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI 7.0.2), currently experiencing a depressive episode of at least 4 weeks and not exceeding 12 months.
- •Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at screening or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF
- •Participant with the following psychiatric history:
- •No history of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.
- •No lifetime history of schizophrenia, other psychotic disorders, dissociative disorders, or neurocognitive disorders.
- •No history of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.
- •History of stable psychiatric comorbidities (e.g., PTSD, OCD) may be included provided these conditions have not required intervention with a prohibited medication within the past 12 months prior to Screening.
排除标准
- •A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.
- •History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
- •A concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal impairment or disease (e.g., participants with eGFR < 30 mL/min), hepatic (including history of severe hepatic impairment), gastrointestinal, or neurological disorder. If there is a history of such disease (except malignancy), but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with participation in the study, the subject may be included.
研究组 & 干预措施
ABBV-932
Participants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up
干预措施: ABBV-932 (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events
时间窗: Up to approximately 29 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
时间窗: Up to week 26
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
时间窗: Up to week 26
12-lead resting ECG will be recorded.
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
时间窗: Up to week 26
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Change From Baseline in Simpson-Angus Scale (SAS)
时间窗: Up to week 26
SAS (Simpson-Angus Scale): is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Minimum: 0 (no symptoms) Maximum: 40 (very severe symptoms; 10 items scored 0-4 each).
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
时间窗: Up to week 26
AIMS (Abnormal Involuntary Movement Scale): assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. Minimum: 0 (no abnormal movements) Maximum: 42 (most severe; 7 items scored 0-4 each), some versions use 0-4 on 10 items for a max of 40/40.
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
时间窗: Up to week 26
BARS (Barnes Akathisia Rating Scale): is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia. Minimum: 0 (no akathisia) Maximum: 14 (severe akathisia; 4 items scored, most items 0-3 or 0-5)
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: Up to week 26
C-SSRS rates an individual's degree of suicidal ideation (SI) and behaviors on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
Change From Baseline in the Epworth Sleepiness Scale (ESS)
时间窗: Up to week 26
ESS (Epworth Sleepiness Scale): is a scale that is intended to measure daytime sleepiness. Minimum: 0 (no sleepiness) Maximum: 24 (severe sleepiness; 8 items scored 0-3 each)
Change From Baseline in the Young Mania Rating Scale (YMRS)
时间窗: Up to week 26
The YMRS (Young Mania Rating Scale): is an 11-item, clinician-rated scale that assesses manic symptoms based on the participant's perception of their condition over the previous 48 hours, as well as the physician's clinical observations during the interview. Minimum: 0 (no mania) Maximum: 60 (severe mania; 11 items, some scored 0-4, others 0-8)
Number of Participants with Abnormal Change in Ocular Examination
时间窗: Up to week 26
Number of participants with abnormal change in ocular examinations in areas like best corrected visual acuity (BCVA), and refraction.
次要结局
未报告次要终点