Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
Recruiting · NCT07220460 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
49 locations listed across 22 US states.
- Ima Clinical Research Phoenix (Alea) /ID# 278047 - Phoenix, Arizona, United States
- Advanced Research Center /ID# 273474 - Anaheim, California, United States
- Axiom Research /ID# 273482 - Colton, California, United States
- Collaborative Neuroscience Research - Garden Grove /ID# 273492 - Garden Grove, California, United States
- Sun Valley Research Center /ID# 273472 - Imperial, California, United States
- Synergy San Diego /ID# 278340 - Lemon Grove, California, United States
- Alliance for Research Alliance for Wellness /ID# 273477 - Long Beach, California, United States
- Nrc Research Institute - Los Angeles /ID# 278450 - Los Angeles, California, United States
- Excell Research /ID# 273483 - Oceanside, California, United States
- Inland Psychiatric Medical Group /ID# 273471 - Temecula, California, United States
- Sunwise Clinical Research /ID# 278165 - Walnut Creek, California, United States
- Connecticut Clinical Research - Cromwell /ID# 278116 - Cromwell, Connecticut, United States
- Clinical Neuroscience Solutions Healthcare - Jacksonville /ID# 278332 - Jacksonville, Florida, United States
- GMI Florida - Central Miami Medical Institute /ID# 273486 - Miami, Florida, United States
- Allied Biomedical Res Inst Inc /ID# 273476 - Miami, Florida, United States
- Floridian Clinical Research - Miami Lakes /ID# 279379 - Miami Lakes, Florida, United States
- K2 Medical Research - Orlando - South Orlando Avenue /ID# 273487 - Orlando, Florida, United States
- Apg Research /ID# 278439 - Orlando, Florida, United States
- Segal Trials - West Broward Outpatient Research Site /ID# 273496 - Tamarac, Florida, United States
- Health Synergy Clinical Research /ID# 279384 - West Palm Beach, Florida, United States
- Trialmed /ID# 278046 - Atlanta, Georgia, United States
- Atlanta Center for Medical Research /ID# 278827 - Atlanta, Georgia, United States
- Revive Research Institute - Elgin /ID# 279756 - Elgin, Illinois, United States
- Benchmark Research /ID# 273490 - Shreveport, Louisiana, United States
- Pharmasite Research, Inc. /ID# 279163 - Baltimore, Maryland, United States
- Elixia - Springfield /ID# 278446 - Springfield, Massachusetts, United States
- MSB Neuroscience /ID# 278168 - Jackson, Mississippi, United States
- Arch Clinical Trials /ID# 273481 - St Louis, Missouri, United States
- Alivation Research /ID# 279464 - Lincoln, Nebraska, United States
- Ima Clinical Research Las Vegas (SMO/Network/Consortium) /ID# 278054 - Las Vegas, Nevada, United States
- Redbird Research /ID# 279475 - Las Vegas, Nevada, United States
- Bio Behavioral Health /ID# 273478 - Toms River, New Jersey, United States
- Integrative Clinical Trials /ID# 278040 - Brooklyn, New York, United States
- Neurobehavioral Research /ID# 273470 - Cedarhurst, New York, United States
- Ima Clinical Research - Manhattan /ID# 278941 - New York, New York, United States
- New Hope Clinical Research - Inpatient unit /ID# 273468 - Charlotte, North Carolina, United States
- Quest Therapeutics of Avon Lake /ID# 273484 - Avon Lake, Ohio, United States
- OSU Psychiatry Department /ID# 273495 - Columbus, Ohio, United States
- Sooner Clinical Research /ID# 273491 - Oklahoma City, Oklahoma, United States
- Summit Research Network - Portland - Northwest Vaughn Street /ID# 278084 - Portland, Oregon, United States
- Lehigh Center for Clinical Research /ID# 273466 - Allentown, Pennsylvania, United States
- FutureSearch Trials of Dallas /ID# 273473 - Dallas, Texas, United States
- Epic Medical Research - DeSoto /ID# 278045 - DeSoto, Texas, United States
- Perceptive Pharma Research /ID# 273485 - Richmond, Texas, United States
- Family Psychiatry Of The Woodlands /ID# 278050 - The Woodlands, Texas, United States
- Northwest Clinical Research Center /ID# 273480 - Bellevue, Washington, United States
- Core Clinical Research /ID# 273498 - Everett, Washington, United States
- Inspira Clinical Research /ID# 274670 - San Juan, Puerto Rico
- BDH Research /ID# 274677 - San Juan, Puerto Rico