NCT06605599CompletedPhase 2
Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder
Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder
Source: ClinicalTrials.gov · Last updated 14 Oct 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. 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 161 (actual)
- First submitted
- 18 Sept 2024
- Start date
- 15 Oct 2024
- Primary completion date
- 12 Nov 2025
- Lead sponsor
- AbbVie
- Diseases
- Bipolar disorder
- NCT number
- NCT06605599
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 161
- From 15 Oct 2024 to the primary completion date, 12 Nov 2025
- 40 sites in 3 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.
Prior treatment
- 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.
- Current use of any antipsychotic, antidepressant, anticonvulsant, mood stabilizer, 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kuramitsu Hospital /ID# 268751 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kaku Mental Clinic /ID# 268020 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kokura Mental Clinic /ID# 268031 Coordinator of this site? Confirm its status | Kitakyushu | Japan | Unknown status |
| Yutaka Clinic /ID# 268026 Coordinator of this site? Confirm its status | Sagamihara | Japan | Unknown status |
| Kawamura Mental Clinic /ID# 268325 Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267065 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| INSPIRA Clinical Research /ID# 267041 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| BDH Research /ID# 267025 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Lehigh Center for Clinical Research /ID# 267451 Coordinator of this site? Confirm its status | Allentown | United States | Unknown status |
| Advanced Research Center /ID# 267716 Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Quest Therapeutics of Avon Lake /ID# 267558 Coordinator of this site? Confirm its status | Avon Lake | United States | Unknown status |
| Northwest Clinical Research Center /ID# 267505 Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Neurobehavioral Research /ID# 267564 Coordinator of this site? Confirm its status | Cedarhurst | United States | Unknown status |
| Coastal Carolina Research Center, LLC /ID# 267550 Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| New Hope Clinical Research - Inpatient unit /ID# 267465 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Center For Emotional Fitness - Cherry Hill /ID# 267661 Coordinator of this site? Confirm its status | Cherry Hill | United States | Unknown status |
| Axiom Research /ID# 267518 Coordinator of this site? Confirm its status | Colton | United States | Unknown status |
| OSU Psychiatry Department /ID# 267730 Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| FutureSearch Trials of Dallas /ID# 267715 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Harmonex /ID# 267504 Coordinator of this site? Confirm its status | Dothan | United States | Unknown status |
| Core Clinical Research /ID# 268534 Coordinator of this site? Confirm its status | Everett | United States | Unknown status |
| CenExel /ID# 267675 Coordinator of this site? Confirm its status | Gaithersburg | United States | Unknown status |
| Collaborative Neuroscience Research - Garden Grove /ID# 267654 Coordinator of this site? Confirm its status | Garden Grove | United States | Unknown status |
| Sun Valley Research Center /ID# 267708 Coordinator of this site? Confirm its status | Imperial | United States | Unknown status |
| Accel Research Sites Network - St. Pete /ID# 267463 Coordinator of this site? Confirm its status | Largo | United States | Unknown status |
| Duplicate_Oasis Clinical Research, LLC /ID# 267969 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Alliance for Research Alliance for Wellness /ID# 267492 Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Suburban Research Associates - Media /ID# 267621 Coordinator of this site? Confirm its status | Media | United States | Unknown status |
| GMI Florida - Central Miami Medical Institute /ID# 267566 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Allied Biomedical Res Inst Inc /ID# 267481 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Excell Research /ID# 267541 Coordinator of this site? Confirm its status | Oceanside | United States | Unknown status |
| Sooner Clinical Research /ID# 267639 Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Perceptive Pharma Research /ID# 267563 Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Benchmark Research /ID# 267626 Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| Arch Clinical Trials /ID# 267507 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Segal Trials - West Broward Outpatient Research Site /ID# 267947 Coordinator of this site? Confirm its status | Tamarac | United States | Unknown status |
| Viking Clinical Research Center - Temecula /ID# 267634 Coordinator of this site? Confirm its status | Temecula | United States | Unknown status |
| Bio Behavioral Health /ID# 267493 Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
| Grayline Research Center /ID# 267466 Coordinator of this site? Confirm its status | Wichita Falls | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.