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Bipolar I DisorderPhase 2NCT06696755

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

A Phase 2 study testing Icalcaprant in people with Bipolar I Disorder and Bipolar II Disorder, run by AbbVie at 33 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar I Disorder, Bipolar II Disorder
What is being tested?
Icalcaprant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
195 participants
Where
33 sitesUnited States
Study dates
3 Feb 2026to Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

33 sites in 1 country. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

33 sites in 1 country

United States33 sites, 33 recruiting

  • Advanced Research Center /ID# 272828

    Anaheim, California, 92805

    Recruiting

  • Georgia Psychiatric Consultants and Advanced Discovery Research /ID# 279438

    Atlanta, Georgia, 30318

    Recruiting

  • Community Clinical Research - Cross Park Drive /ID# 272940

    Austin, Texas, 78754

    Recruiting

  • Northwest Clinical Research Center /ID# 272847

    Bellevue, Washington, 98007

    Recruiting

  • Sanro Clinical Research Group /ID# 279462

    Bryant, Arkansas, 72022

    Recruiting

  • Chandler Clinical Research Trials /ID# 274500

    Chandler, Arizona, 85224

    Recruiting

  • Pillar Clinical Research - Chicago /ID# 272823

    Chicago, Illinois, 60641

    Site Coordinator, 2245347332

    Recruiting

  • University Of Cincinnati Medical Center /ID# 274160

    Cincinnati, Ohio, 45219

    Recruiting

  • The Ohio State University /ID# 272954

    Columbus, Ohio, 43210

    Recruiting

  • Core Clinical Research /ID# 272955

    Everett, Washington, 98201

    Recruiting

  • Sarkis Clinical Trials- Gainesville /ID# 272861

    Gainesville, Florida, 32607

    Recruiting

  • Collaborative Neuroscience Research - Garden Grove /ID# 271917

    Garden Grove, California, 92845

    Recruiting

  • CenExel Hollywood FL /ID# 273101

    Hollywood, Florida, 33024

    Recruiting

  • Elixia - Houston /ID# 279200

    Houston, Texas, 77007

    Recruiting

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

    Huntsville, Alabama, 35801

    Recruiting

  • Accel Research Sites Network - St. Pete /ID# 272962

    Largo, Florida, 33777

    Recruiting

  • Mind Matters Psychiatry /ID# 273536

    Missouri City, Texas, 77459-5204

    Recruiting

  • Catalina Research Institute /ID# 272831

    Montclair, California, 91763

    Recruiting

  • Manhattan Behavioral Medicine /ID# 279769

    New York, New York, 10036

    Recruiting

  • Excell Research /ID# 272854

    Oceanside, California, 92056

    Recruiting

  • Sooner Clinical Research /ID# 272856

    Oklahoma City, Oklahoma, 73116

    Recruiting

  • Pacific Neuropsychiatric Specialists - Orange /ID# 273118

    Orange, California, 92868

    Recruiting

  • Apg Research /ID# 272925

    Orlando, Florida, 32803

    Recruiting

  • Combined Research Orlando /ID# 279458

    Orlando, Florida, 32814

    Recruiting

  • Clinical Research Center Of Florida /ID# 278790

    Pompano Beach, Florida, 33060

    Recruiting

  • Pillar Clinical Research - Richardson /ID# 272821

    Richardson, Texas, 75080

    Recruiting

  • St. Johns Center for Clinical Research - Saint Augustine Location /ID# 279465

    Saint Augustine, Florida, 32086

    Recruiting

  • Saint Charles Psychiatric Associates /ID# 279239

    Saint Charles, Missouri, 63304

    Recruiting

  • Schuster Medical Research Institute /ID# 272848

    Sherman Oaks, California, 91403

    Recruiting

  • Family Psychiatry Of The Woodlands /ID# 275177

    The Woodlands, Texas, 77381

    Recruiting

  • Del Sol Research Management - East Tanque Verde Road - Tucson /ID# 279767

    Tucson, Arizona, 85715

    Recruiting

  • Amr Conventions Research /ID# 272867

    Warrenville, Illinois, 60555

    Recruiting

  • Neuroscience Institute - West Palm Beach /ID# 272922

    West Palm Beach, Florida, 33407

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, 6-Week, Double Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Bipolar Depression

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.

Read more

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.

Being tested
Icalcaprant, Placebo for Icalcaprant
Keywords
Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder, lcalcaprant, ABBV-1354, CVL-354
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IcalcaprantDrug

    Also called ABBV-1354, CVL-354

    Oral Capsules

  • Placebo for IcalcaprantDrug

    Oral Capsules

Study groups in NCT06696755
Study groupRoleWhat they receive
Group 1: Icalcaprant Dose AExperimentalParticipants will receive oral Icalcaprant dose A once daily for 6 weeks and followed for 4 weeks.
Receives: Drug: Icalcaprant
Group 2: Icalcaprant Dose BExperimentalParticipants will receive oral Icalcaprant dose B once daily for 6 weeks and followed for 4 weeks.
Receives: Drug: Icalcaprant
Group 3: Placebo for IcalcaprantPlacebo comparatorParticipants will receive oral placebo for Icalcaprant daily for 6 weeks and followed for 4 weeks.
Receives: Drug: Placebo for Icalcaprant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score

    MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).

    Measured: Up to approximately Week 6

  2. Number of Participants with Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study

    Measured: Up to approximately 10 weeks

Secondary outcomes (1)

  1. Change from Baseline to Week 6 in Clinician Global Impression of Severity - Bipolar Disorder (CGI-S-BP) score

    Clinician Global Impression of Severity - Bipolar Disorder (CGI-S-BP) is a clinician-reported measure of severity of mania, depression, and overall bipolar disorder. Clinicians are asked to consider their total clinical experience with bipolar subjects and assess how severely ill has the participant been during the past 7 days. Response options range from 'Normal, not ill' to 'Very severely ill'.

    Measured: Up to approximately Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2024
  2. Study start3 Feb 2026
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
195 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06696755
Sponsor's protocol ID
M25-526
Status last verified
Aug 2026
First submitted
18 Nov 2024
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Icalcaprant in people with Bipolar I Disorder and Bipolar II Disorder, run by AbbVie at 33 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score (time frame: Up to approximately Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06696755.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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