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A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder

ClinicalTrials.gov IDNCT06696755

PhasePHASE2

Enrollment195

SponsorAbbVie

Age18 Years

SexALL

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Conditions studied

Bipolar I Disorder, Bipolar II Disorder

About this study

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. This study will assess how safe and effective Icalcaprant is in treating adult participants with bipolar I or II disorder. Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to a placebo. Around 195 adult participants with bipolar I or II disorder will be enrolled in approximately 35 sites across the United States of America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 4-week safety follow-up period. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular 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: Icalcaprant — Oral Capsules
Drug: Placebo for Icalcaprant — Oral Capsules

Primary outcomes

Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score (Up to approximately Week 6)
Number of Participants with Adverse Events (AEs) (Up to approximately 10 weeks)

Eligibility information

Inclusion Criteria: * Participants with a diagnosis of bipolar I or II according to the DSM-5-TR without psychotic features, confirmed by the MINI 7.0.2, and currently experiencing an MDE beginning at least 4 weeks prior to consent and not exceeding 12 months prior to Screening. * Body Mass Index (BMI) is \>= 18.0 to ≤\<= 35.0 kg/m\^2. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG. * CGI-S-BP score of ≥ 4 for depression and overall bipolar illness at screening (Visit 1) and baseline (Visit 2). * YMRS total score \<= 12 at screening (Visit 1) and baseline (Visit 2). * Participants on treatment with a single mood stabilizer (lithium, valproate, or lamotrigine), maintained at a stable dose for \>= 28 days prior to screening. Current mood stabilizer dose must remain unchanged for the duration of the study. * If taking lithium or valproate, participant must have a therapeutic blood level at screening of lithium (0.4 - 1.2 mg/dL) or valproate (50 - 125 mg/dL). * If taking lamotrigine, participant should be taking a dose within the FDA accepted range (50-400 mg/day, target dose is 200 mg/day) and investigator clinical judgment determines that the dose the participant is taking is likely to prevent onset of mood episodes. Exclusion Criteria: * 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. * History of or active medical conditions(s) 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, hepatic, gastrointestinal, or neurological disorder (if there is a history of such disease 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 the participant's participation in the study, the participant may be included in the study).

Study locations

University of Alabama - Huntsville Regional Medical Campus /ID# 272951, Huntsville, Alabama 35801 United States
Chandler Clinical Research Trials /ID# 274500, Chandler, Arizona 85224 United States
Del Sol Research Management - East Tanque Verde Road - Tucson /ID# 279767, Tucson, Arizona 85715 United States
Sanro Clinical Research Group /ID# 279462, Bryant, Arkansas 72022 United States
Advanced Research Center /ID# 272828, Anaheim, California 92805 United States
Collaborative Neuroscience Research - Garden Grove /ID# 271917, Garden Grove, California 92845 United States
Catalina Research Institute /ID# 272831, Montclair, California 91763 United States
Excell Research /ID# 272854, Oceanside, California 92056 United States
Pacific Neuropsychiatric Specialists - Orange /ID# 273118, Orange, California 92868 United States
Schuster Medical Research Institute /ID# 272848, Sherman Oaks, California 91403 United States

Showing 10 of 33 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.