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A Study of Icalcaprant for Bipolar I or II Disorder

This study is looking into how safe and effective an investigational drug called Icalcaprant is for adults with bipolar I or II disorder who are currently experiencing a depressive episode. You might be able to join if you are between 18 and 65 years old, have a diagnosis of bipolar I or II disorder without psychotic features, and your depressive episode started within the last year. The main goals are to see how much your depression symptoms change over about 6 weeks, using a scale called the MADRS (Montgomery-Åsberg Depression Rating Scale), and to track any side effects over about 10 weeks. Around 195 adults will participate across the United States. You will be placed into one of three groups, and there's a 1 in 3 chance you'll receive a placebo (an inactive substance) instead of Icalcaprant.

Study design
This is an interventional study where participants are randomly assigned to one of three treatment groups, including a placebo group. Approximately 195 adult participants will be enrolled.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for up to approximately 10 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06696755

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

Recruiting
PHASE2Ages 18–65InterventionalTreatment
AbbVie
~195 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:IcalcaprantPlacebo for Icalcaprant

At a glance

Recruiting sites
33 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score
Measured over Up to approximately Week 6
+1 more outcome measured

Conditions

Bipolar I Disorder
Bipolar II Disorder

Explore related trials

Bipolar I disorderBipolar II Disorder

Where it's being run

33 sites across 13 states
Florida8
California6
Texas5
Arizona2
Illinois2
Ohio2
Washington2
Alabama1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total scoreUp to approximately Week 6

    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).

  • Number of Participants with Adverse Events (AEs)Up to approximately 10 weeks

    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