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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
NCT06696755 · View on ClinicalTrials.gov ↗
Study 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. 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 Studied
Interventions
- DRUG Icalcaprant
- DRUG Placebo for Icalcaprant
Study Locations (20)
California
- Advanced Research Center /ID# 272828 — Anaheim
- Collaborative Neuroscience Research - Garden Grove /ID# 271917 — Garden Grove
- Catalina Research Institute, LLC /ID# 272831 — Montclair
- Excell Research /ID# 272854 — Oceanside
- Pacific Neuropsychiatric Specialists - Orange /ID# 273118 — Orange
- Schuster Medical Research Institute /ID# 272848 — Sherman Oaks
Florida
- CenExcel Clinical Research - Main Facility /ID# 273101 — Hollywood
- Accel Research Sites Network - St. Pete /ID# 272962 — Largo
- Apg Research /ID# 272925 — Orlando
- Combined Research Orlando Phase I-IV /ID# 279458 — Orlando
- Clinical Research Center Of Florida /ID# 278790 — Pompano Beach
- Neuroscience Institute - West Palm Beach /ID# 272922 — West Palm Beach
Illinois
- Pillar Clinical Research - Chicago /ID# 272823 — Chicago
- Amr Conventions Research /ID# 272867 — Warrenville
Ohio
- University Of Cincinnati Medical Center /ID# 274160 — Cincinnati
- The Ohio State University /ID# 272954 — Columbus
Arkansas
- Sanro Clinical Research Group /ID# 279462 — Bryant
Georgia
- Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 279438 — Atlanta
New York
- Manhattan Behavioral Medicine /ID# 279769 — New York
Oklahoma
- Sooner Clinical Research /ID# 272856 — Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2026-02-03 |
| Est. Completion | 2027-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06696755
The ClinicalTrials.gov registry entry for NCT06696755 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Bipolar I Disorder appearing as the primary indexed condition, and to 2 interventions — of which Icalcaprant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06696755 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06696755 about?
NCT06696755 is a clinical study titled "A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder". 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 in...
What is the current status of trial NCT06696755?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2026-02-03. Estimated completion is 2027-11.
What conditions does trial NCT06696755 study?
This clinical trial studies the following conditions: Bipolar I Disorder, Bipolar II Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06696755?
The interventions under investigation include: Icalcaprant (DRUG), Placebo for Icalcaprant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06696755?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06696755 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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