--- title: Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder nct_id: NCT06605599 overall_status: COMPLETED phase: PHASE2 sponsor: AbbVie study_type: INTERVENTIONAL primary_condition: Bipolar I Disorder countries: United States, Japan, Puerto Rico canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06605599.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06605599" ct_last_update_post_date: 2026-01-12 last_seen_at: "2026-05-12T07:24:42.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder **Official Title:** 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 **NCT ID:** [NCT06605599](https://clinicaltrials.gov/study/NCT06605599) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 161 - **Lead Sponsor:** AbbVie - **Conditions:** Bipolar I Disorder, Bipolar II Disorder - **Start Date:** 2024-10-15 - **Completion Date:** 2025-12-10 - **CT.gov Last Update:** 2026-01-12 ## Brief Summary 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 65 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. 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. * 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. ``` ## Arms - **ABBV-932 Dose A** (EXPERIMENTAL) — Participants will receive ABBV-932 Dose A. - **ABBV-932 Dose B** (EXPERIMENTAL) — Participants will receive ABBV-932 Dose B. - **ABBV-932 Dose C** (EXPERIMENTAL) — Participants will receive ABBV-932 Dose C. - **Placebo for ABBV-932** (PLACEBO_COMPARATOR) — Participants will receive placebo. ## Interventions - **ABBV-932** (DRUG) — Oral Capsule - **Placebo for ABBV-932** (DRUG) — Oral Capsule ## Primary Outcomes - **Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score** _(time frame: Up to Week 6)_ — The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. ## Secondary Outcomes - **Change From Baseline in Clinical Global Impression-Severity - Bipolar Disorder (CGI-S-BP)** _(time frame: Up to Week 6)_ - **Change From Baseline in Functioning Assessment Short Test (FAST) Total Score** _(time frame: Up to Week 6)_ - **Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score** _(time frame: Up to Week 6)_ ## Locations (40) - Harmonex /ID# 267504, Dothan, Alabama, United States - Advanced Research Center /ID# 267716, Anaheim, California, United States - Axiom Research /ID# 267518, Colton, California, United States - Collaborative Neuroscience Research - Garden Grove /ID# 267654, Garden Grove, California, United States - Sun Valley Research Center /ID# 267708, Imperial, California, United States - Alliance for Research Alliance for Wellness /ID# 267492, Long Beach, California, United States - Excell Research /ID# 267541, Oceanside, California, United States - Viking Clinical Research Center - Temecula /ID# 267634, Temecula, California, United States - Accel Research Sites Network - St. Pete /ID# 267463, Largo, Florida, United States - GMI Florida - Central Miami Medical Institute /ID# 267566, Miami, Florida, United States - Allied Biomedical Res Inst Inc /ID# 267481, Miami, Florida, United States - K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567, Orlando, Florida, United States - Segal Trials - West Broward Outpatient Research Site /ID# 267947, Tamarac, Florida, United States - Benchmark Research /ID# 267626, Shreveport, Louisiana, United States - CenExel /ID# 267675, Gaithersburg, Maryland, United States - Arch Clinical Trials /ID# 267507, St Louis, Missouri, United States - Duplicate_Oasis Clinical Research, LLC /ID# 267969, Las Vegas, Nevada, United States - Center For Emotional Fitness - Cherry Hill /ID# 267661, Cherry Hill, New Jersey, United States - Bio Behavioral Health /ID# 267493, Toms River, New Jersey, United States - Neurobehavioral Research /ID# 267564, Cedarhurst, New York, United States - New Hope Clinical Research - Inpatient unit /ID# 267465, Charlotte, North Carolina, United States - Quest Therapeutics of Avon Lake /ID# 267558, Avon Lake, Ohio, United States - OSU Psychiatry Department /ID# 267730, Columbus, Ohio, United States - Sooner Clinical Research /ID# 267639, Oklahoma City, Oklahoma, United States - Lehigh Center for Clinical Research /ID# 267451, Allentown, Pennsylvania, United States - Suburban Research Associates - Media /ID# 267621, Media, Pennsylvania, United States - Coastal Carolina Research Center, LLC /ID# 267550, Charleston, South Carolina, United States - FutureSearch Trials of Dallas /ID# 267715, Dallas, Texas, United States - Perceptive Pharma Research /ID# 267563, Richmond, Texas, United States - Grayline Research Center /ID# 267466, Wichita Falls, Texas, United States - Northwest Clinical Research Center /ID# 267505, Bellevue, Washington, United States - Core Clinical Research /ID# 268534, Everett, Washington, United States - Kokura Mental Clinic /ID# 268031, Kitakyushu, Fukuoka, Japan - Kawamura Mental Clinic /ID# 268325, Sapporo, Hokkaido, Japan - Yutaka Clinic /ID# 268026, Sagamihara, Kanagawa, Japan - Kaku Mental Clinic /ID# 268020, Fukuoka, Japan - Kuramitsu Hospital /ID# 268751, Fukuoka, Japan - INSPIRA Clinical Research /ID# 267041, San Juan, Puerto Rico - Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267065, San Juan, Puerto Rico - BDH Research /ID# 267025, San Juan, Puerto Rico ## Recent Field Changes (last 30 days) - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.harmonex /id# 267504|dothan|alabama|united states` — added _(2026-05-12)_ - `locations.advanced research center /id# 267716|anaheim|california|united states` — added _(2026-05-12)_ - `locations.axiom research /id# 267518|colton|california|united states` — added _(2026-05-12)_ - `locations.collaborative neuroscience research - garden grove /id# 267654|garden grove|california|united states` — added _(2026-05-12)_ - `locations.kuramitsu hospital /id# 268751|fukuoka||japan` — added _(2026-05-12)_ - `locations.sun valley research center /id# 267708|imperial|california|united states` — added _(2026-05-12)_ - `locations.alliance for research alliance for wellness /id# 267492|long beach|california|united states` — added _(2026-05-12)_ - `locations.excell research /id# 267541|oceanside|california|united states` — added _(2026-05-12)_ - `locations.viking clinical research center - temecula /id# 267634|temecula|california|united states` — added _(2026-05-12)_ - `locations.accel research sites network - st. pete /id# 267463|largo|florida|united states` — added _(2026-05-12)_ - `locations.gmi florida - central miami medical institute /id# 267566|miami|florida|united states` — added _(2026-05-12)_ - `locations.allied biomedical res inst inc /id# 267481|miami|florida|united states` — added _(2026-05-12)_ - `locations.k2 medical research - orlando - south orlando avenue /id# 267567|orlando|florida|united states` — added _(2026-05-12)_ - `locations.segal trials - west broward outpatient research site /id# 267947|tamarac|florida|united states` — added _(2026-05-12)_ - `locations.benchmark research /id# 267626|shreveport|louisiana|united states` — added _(2026-05-12)_ - `locations.cenexel /id# 267675|gaithersburg|maryland|united states` — added _(2026-05-12)_ - `locations.arch clinical trials /id# 267507|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.duplicate_oasis clinical research, llc /id# 267969|las vegas|nevada|united states` — added _(2026-05-12)_ - `locations.center for emotional fitness - cherry hill /id# 267661|cherry hill|new jersey|united states` — added _(2026-05-12)_ - `locations.bio behavioral health /id# 267493|toms river|new jersey|united states` — added _(2026-05-12)_ - `locations.neurobehavioral research /id# 267564|cedarhurst|new york|united states` — added _(2026-05-12)_ - `locations.new hope clinical research - inpatient unit /id# 267465|charlotte|north carolina|united states` — added _(2026-05-12)_ - `locations.quest therapeutics of avon lake /id# 267558|avon lake|ohio|united states` — added _(2026-05-12)_ - `locations.osu psychiatry department /id# 267730|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.sooner clinical research /id# 267639|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.lehigh center for clinical research /id# 267451|allentown|pennsylvania|united states` — added _(2026-05-12)_ - `locations.suburban research associates - media /id# 267621|media|pennsylvania|united states` — added _(2026-05-12)_ - `locations.coastal carolina research center, llc /id# 267550|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.futuresearch trials of dallas /id# 267715|dallas|texas|united states` — added _(2026-05-12)_ - `locations.perceptive pharma research /id# 267563|richmond|texas|united states` — added _(2026-05-12)_ - `locations.grayline research center /id# 267466|wichita falls|texas|united states` — added _(2026-05-12)_ - `locations.northwest clinical research center /id# 267505|bellevue|washington|united states` — added _(2026-05-12)_ - `locations.core clinical research /id# 268534|everett|washington|united states` — added _(2026-05-12)_ - `locations.kokura mental clinic /id# 268031|kitakyushu|fukuoka|japan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06605599.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06605599* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*