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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants with a diagnosis of bipolar I or II according to the (Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) DSM-5-TR) without psychotic features, confirmed by the Mini International Neuropsychiatric Interview (MINI) 7.0.2, and currently experiencing an (major depressive episode) MDE beginning at least 4 weeks prior to consent and not exceeding 6 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 (0.8 - 1.2 mg/dL) or valproate (50 - 125 mg/dL). - If taking lamotrigine, participant must be taking a locally approved maintenance dose.

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: Icalcaprant Dose A 		Participants will receive oral Icalcaprant dose A once daily for 6 weeks and followed for 4 weeks.
  • Drug: Icalcaprant
    Oral Capsules
    Other names:
    • ABBV-1354
    • CVL-354
Experimental
Group 2: Icalcaprant Dose B 		Participants will receive oral Icalcaprant dose B once daily for 6 weeks and followed for 4 weeks.
  • Drug: Icalcaprant
    Oral Capsules
    Other names:
    • ABBV-1354
    • CVL-354
Placebo Comparator
Group 3: Placebo for Icalcaprant 		Participants will receive oral placebo for Icalcaprant daily for 6 weeks and followed for 4 weeks.
  • Drug: Placebo for Icalcaprant
    Oral Capsules

Recruiting Locations

University of Alabama - Huntsville Regional Medical Campus /ID# 272951
Huntsville, Alabama 35801

Chandler Clinical Research Trials /ID# 274500
Chandler, Arizona 85224

Sanro Clinical Research Group /ID# 279462
Bryant, Arkansas 72022

Advanced Research Center /ID# 272828
Anaheim, California 92805

Collaborative Neuroscience Research - Garden Grove /ID# 271917
Garden Grove, California 92845

Catalina Research Institute, LLC /ID# 272831
Montclair, California 91763

Excell Research /ID# 272854
Oceanside, California 92056

Pacific Neuropsychiatric Specialists - Orange /ID# 273118
Orange, California 92868

Schuster Medical Research Institute /ID# 272848
Sherman Oaks, California 91403

CenExcel Clinical Research - Main Facility /ID# 273101
Hollywood, Florida 33024

Accel Research Sites Network - St. Pete /ID# 272962
Largo, Florida 33777

Apg Research /ID# 272925
Orlando, Florida 32803

Combined Research Orlando Phase I-IV /ID# 279458
Orlando, Florida 32814

Clinical Research Center Of Florida /ID# 278790
Pompano Beach, Florida 33060

Neuroscience Institute - West Palm Beach /ID# 272922
West Palm Beach, Florida 33407

Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 279438
Atlanta, Georgia 30318

Pillar Clinical Research - Chicago /ID# 272823
Chicago, Illinois 60641
Contact:
Site Coordinator
2245347332

Amr Conventions Research /ID# 272867
Warrenville, Illinois 60555

St. Charles Psychiatric Associates /ID# 279239
Saint Charles, Missouri 63304

Manhattan Behavioral Medicine /ID# 279769
New York, New York 10036

University Of Cincinnati Medical Center /ID# 274160
Cincinnati, Ohio 45219

The Ohio State University /ID# 272954
Columbus, Ohio 43210

Sooner Clinical Research /ID# 272856
Oklahoma City, Oklahoma 73116

Community Clinical Research - Austin - Cross Park Drive /ID# 272940
Austin, Texas 78754

Elixia - Houston /ID# 279200
Houston, Texas 77007

Pillar Clinical Research - Richardson /ID# 272821
Richardson, Texas 75080

Northwest Clinical Research Center /ID# 272847
Bellevue, Washington 98007

Core Clinical Research /ID# 272955
Everett, Washington 98201

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.