Depressive Episodes Associated with Bipolar I or II Disorder: A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932

JRCT ID: jRCT2061240082

Registered date:12/11/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Bipolar I Disorder
Bipolar II Disorder

• Date of first enrollment: 12/11/2024
• Target sample size: 16
• Countries of recruitment: United States,Japan,Puerto Rico,Japan
• Study type: Interventional
• Intervention(s): ABBV-932 Dose A, Dose B, Dose C, or Placebo

Outcome(s)

• Primary Outcome: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Secondary Outcome

- Change From Baseline in Clinical Global Impression-Severity - Bipolar Disorder (CGI-S-BP)
- Change From Baseline in Functioning Assessment Short Test (FAST) Total Score
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

- 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.
- Have a maximum score of 12 on the Young Mania Rating Scale (YMRS) at baseline.

Exclude criteria

- 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.
- History, or current use of treatment with any antipsychotic, antidepressant, anticonvulsant, mood stabilizer, sedative/hypnotic medication, 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.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT06605599