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New pill could ease bipolar depression – trial underway

NCT ID NCT06696755

Symptom relief Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tests an experimental drug called icalcaprant for treating depression in people with bipolar I or II disorder. About 195 adults will take either the drug or a placebo daily for 6 weeks. Researchers will measure changes in depression symptoms and watch for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 195 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar I disorder bipolar II disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar I disorder Bipolar ii disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Largo, Florida, 33777, United States

  • Advanced Research Center /ID# 272828

    RECRUITING

    Anaheim, California, 92805, United States

  • Amr Conventions Research /ID# 272867

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Apg Research /ID# 272925

    RECRUITING

    Orlando, Florida, 32803, United States

  • Catalina Research Institute /ID# 272831

    RECRUITING

    Montclair, California, 91763, United States

  • CenExel Hollywood FL /ID# 273101

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Chandler Clinical Research Trials /ID# 274500

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Clinical Research Center Of Florida /ID# 278790

    RECRUITING

    Pompano Beach, Florida, 33060, United States

  • Collaborative Neuroscience Research - Garden Grove /ID# 271917

    RECRUITING

    Garden Grove, California, 92845, United States

  • Combined Research Orlando /ID# 279458

    RECRUITING

    Orlando, Florida, 32814, United States

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

    RECRUITING

    Austin, Texas, 78754, United States

  • Core Clinical Research /ID# 272955

    RECRUITING

    Everett, Washington, 98201, United States

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

    RECRUITING

    Tucson, Arizona, 85715, United States

  • Elixia - Houston /ID# 279200

    RECRUITING

    Houston, Texas, 77007, United States

  • Excell Research /ID# 272854

    RECRUITING

    Oceanside, California, 92056, United States

  • Family Psychiatry Of The Woodlands /ID# 275177

    RECRUITING

    The Woodlands, Texas, 77381, United States

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

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Manhattan Behavioral Medicine /ID# 279769

    RECRUITING

    New York, New York, 10036, United States

  • Mind Matters Psychiatry /ID# 273536

    RECRUITING

    Missouri City, Texas, 77459-5204, United States

  • Neuroscience Institute - West Palm Beach /ID# 272922

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Northwest Clinical Research Center /ID# 272847

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Pacific Neuropsychiatric Specialists - Orange /ID# 273118

    RECRUITING

    Orange, California, 92868, United States

  • Pillar Clinical Research - Chicago /ID# 272823

    RECRUITING

    Chicago, Illinois, 60641, United States

  • Pillar Clinical Research - Richardson /ID# 272821

    RECRUITING

    Richardson, Texas, 75080, United States

  • Saint Charles Psychiatric Associates /ID# 279239

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • Sanro Clinical Research Group /ID# 279462

    RECRUITING

    Bryant, Arkansas, 72022, United States

  • Sarkis Clinical Trials- Gainesville /ID# 272861

    RECRUITING

    Gainesville, Florida, 32607, United States

  • Schuster Medical Research Institute /ID# 272848

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • Sooner Clinical Research /ID# 272856

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

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

    RECRUITING

    Saint Augustine, Florida, 32086, United States

  • The Ohio State University /ID# 272954

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University Of Cincinnati Medical Center /ID# 274160

    RECRUITING

    Cincinnati, Ohio, 45219, United States

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

    RECRUITING

    Huntsville, Alabama, 35801, United States

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