Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder

AbbVie

Status and phase: Enrolling; Phase 2

Conditions: Bipolar II Disorder; Bipolar I Disorder

Treatments: Drug: Placebo for ABBV-932; Drug: ABBV-932

Study type: Interventional

Funder types: Industry

Identifiers

NCT06605599

M23-894

Details and patient eligibility

About

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

ABBV-932 Dose A

Experimental group

Description:

Participants will receive ABBV-932 Dose A.

Treatment:

Drug: ABBV-932

ABBV-932 Dose B

Experimental group

Description:

Participants will receive ABBV-932 Dose B.

Treatment:

Drug: ABBV-932

ABBV-932 Dose C

Experimental group

Description:

Participants will receive ABBV-932 Dose C.

Treatment:

Drug: ABBV-932

Placebo for ABBV-932

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Drug: Placebo for ABBV-932