NCT07220460Active, not recruitingPhase 2
Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
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
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 26 Sept 2025
- Start date
- 30 Sept 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- AbbVie
- Diseases
- Bipolar disorder
- NCT number
- NCT07220460
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 84
- From 30 Sept 2025 to the primary completion date, 31 Mar 2027
- 49 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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.
Other
- A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (49)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inspira Clinical Research /ID# 274670 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| BDH Research /ID# 274677 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Lehigh Center for Clinical Research /ID# 273466 Coordinator of this site? Confirm its status | Allentown | United States | Unknown status |
| Advanced Research Center /ID# 273474 Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Atlanta Center for Medical Research /ID# 278827 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Trialmed /ID# 278046 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Quest Therapeutics of Avon Lake /ID# 273484 Coordinator of this site? Confirm its status | Avon Lake | United States | Unknown status |
| Pharmasite Research, Inc. /ID# 279163 Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Northwest Clinical Research Center /ID# 273480 Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Integrative Clinical Trials /ID# 278040 Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Neurobehavioral Research /ID# 273470 Coordinator of this site? Confirm its status | Cedarhurst | United States | Unknown status |
| New Hope Clinical Research /ID# 273468 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Axiom Research /ID# 273482 Coordinator of this site? Confirm its status | Colton | United States | Unknown status |
| OSU Psychiatry Department /ID# 273495 Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Connecticut Clinical Research - Cromwell /ID# 278116 Coordinator of this site? Confirm its status | Cromwell | United States | Unknown status |
| Future Search Trials of Dallas /ID# 273473 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Epic Medical Research - DeSoto /ID# 278045 Coordinator of this site? Confirm its status | DeSoto | United States | Unknown status |
| Revive Research Institute - Elgin /ID# 279756 Coordinator of this site? Confirm its status | Elgin | United States | Unknown status |
| Core Clinical Research /ID# 273498 Coordinator of this site? Confirm its status | Everett | United States | Unknown status |
| Collaborative Neuroscience Research - Garden Grove /ID# 273492 Coordinator of this site? Confirm its status | Garden Grove | United States | Unknown status |
| Sun Valley Research Center /ID# 273472 Coordinator of this site? Confirm its status | Imperial | United States | Unknown status |
| MSB Neuroscience /ID# 278168 Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Clinical Neuroscience Solutions Healthcare - Jacksonville /ID# 278332 Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Redbird Research /ID# 279475 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Ima Clinical Research Las Vegas /ID# 278054 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Segal Trials - Lauderhill /ID# 273496 Coordinator of this site? Confirm its status | Lauderhill | United States | Unknown status |
| Synergy San Diego /ID# 278340 Coordinator of this site? Confirm its status | Lemon Grove | United States | Unknown status |
| Alivation Research - Lincoln /ID# 279464 Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| Alliance for Research Alliance for Wellness /ID# 273477 Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Nrc Research Institute - Los Angeles /ID# 278450 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| K2 Medical Research -Maitland /ID# 273487 Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| GMI Florida - Central Miami Medical Institute (SMO/Network/Consortium) /ID# 273486 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Allied Biomedical Res Inst Inc /ID# 273476 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Floridian Clinical Research - Miami Lakes /ID# 279379 Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Ima Clinical Research - Manhattan /ID# 278941 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Excell Research /ID# 273483 Coordinator of this site? Confirm its status | Oceanside | United States | Unknown status |
| Sooner Clinical Research /ID# 273491 Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Apg Research /ID# 278439 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Ima Clinical Research Phoenix /ID# 278047 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Summit Research Network - Portland - Northwest Vaughn Street /ID# 278084 Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Perceptive Pharma Research /ID# 273485 Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Benchmark Research /ID# 273490 Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| Voltaire - Springfield /ID# 278446 Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Arch Clinical Trials /ID# 273481 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Inland Psychiatric Medical Group /ID# 273471 Coordinator of this site? Confirm its status | Temecula | United States | Unknown status |
| Family Psychiatry Of The Woodlands /ID# 278050 Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Bio Behavioral Health /ID# 273478 Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
| Sunwise Clinical Research /ID# 278165 Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Health Synergy Clinical Research - West Palm Beach /ID# 279384 Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.