Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

ABBV-932: Oral Capsule

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of Participants Experiencing Adverse Events — 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 — 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) — 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 — 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) — 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) — 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) — 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) — 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) — 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) — 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 — Up to week 26
  Number of participants with abnormal change in ocular examinations in areas like best corrected visual acuity (BCVA), and refraction.

Trial sites (49)

+ 9 more sites — see the full list on the official registry below.

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