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NCT06696755 · ClinicalTrials.gov registry record · Phase 2
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 of Bipolar I Disorder and Bipolar II Disorder, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
- 20
- Study locations
NCT06696755: Recruiting Phase 2 study of Bipolar I Disorder and Bipolar II Disorder, sponsored by AbbVie.
NCT06696755 is a Phase 2 study of Bipolar I Disorder and Bipolar II Disorder that is actively recruiting participants, run by AbbVie. The registered enrollment target is 195 participants, below the 322-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06696755, a Phase 2 study of Bipolar I Disorder and Bipolar II Disorder, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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).
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 |
What NCT06696755 shows while recruiting
NCT06696755 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, below the 322-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (39% lower).
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.
NCT06696755 names 20 study sites across 8 states, led by California, Florida, Illinois.
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.
What interventions are being tested in trial NCT06696755?
The interventions under investigation include: Icalcaprant (DRUG), Placebo for Icalcaprant (DRUG).
Who is sponsoring clinical trial NCT06696755?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Bipolar I Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06696755's enrollment target sits among peer trials
195 14th of 26 higher than 13 of 26 other Bipolar I Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar I Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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