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

Official title

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

Overview

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.

Interventions

• Drug ABBV-932
  Oral Capsule

Primary outcome measures

• Number of Participants Experiencing Adverse Events [Time frame: Up to approximately 29 weeks]
• Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements [Time frame: Up to week 26]
• Number of Participants with Change from Baseline in Electrocardiogram (ECG) [Time frame: Up to week 26]
• Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed [Time frame: Up to week 26]
• Change From Baseline in Simpson-Angus Scale (SAS) [Time frame: Up to week 26]
• Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) [Time frame: Up to week 26]
• Change From Baseline in Barnes Akathisia Rating Scale (BARS) [Time frame: Up to week 26]
• Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Up to week 26]
• Change From Baseline in the Epworth Sleepiness Scale (ESS) [Time frame: Up to week 26]
• Change From Baseline in the Young Mania Rating Scale (YMRS) [Time frame: Up to week 26]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 47 centers

• Ima Clinical Research Phoenix (Alea) /ID# 278047 — Phoenix
• Advanced Research Center /ID# 273474 — Anaheim
• Axiom Research /ID# 273482 — Colton
• Collaborative Neuroscience Research - Garden Grove /ID# 273492 — Garden Grove
• Sun Valley Research Center /ID# 273472 — Imperial
• Synergy San Diego /ID# 278340 — Lemon Grove
• Alliance for Research Alliance for Wellness /ID# 273477 — Long Beach
• Nrc Research Institute - Los Angeles /ID# 278450 — Los Angeles
• … and 39 more centers

Puerto Rico · 2 centers

• Inspira Clinical Research /ID# 274670 — San Juan
• BDH Research /ID# 274677 — San Juan

Identifiers

NCT: NCT07220460 · M25-456

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗