A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
Public ClinicalTrials.gov record NCT06696755. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06696755
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 195 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2, 2026
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2027
- Last update posted
- Aug 13, 2026
2026 – 2027
United States locations
- U.S. sites
- 33
- U.S. states
- 13
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama - Huntsville Regional Medical Campus /ID# 272951 | Huntsville | Alabama | 35801 | Recruiting |
| Chandler Clinical Research Trials /ID# 274500 | Chandler | Arizona | 85224 | Recruiting |
| Del Sol Research Management - East Tanque Verde Road - Tucson /ID# 279767 | Tucson | Arizona | 85715 | Recruiting |
| Sanro Clinical Research Group /ID# 279462 | Bryant | Arkansas | 72022 | Recruiting |
| Advanced Research Center /ID# 272828 | Anaheim | California | 92805 | Recruiting |
| Collaborative Neuroscience Research - Garden Grove /ID# 271917 | Garden Grove | California | 92845 | Recruiting |
| Catalina Research Institute /ID# 272831 | Montclair | California | 91763 | Recruiting |
| Excell Research /ID# 272854 | Oceanside | California | 92056 | Recruiting |
| Pacific Neuropsychiatric Specialists - Orange /ID# 273118 | Orange | California | 92868 | Recruiting |
| Schuster Medical Research Institute /ID# 272848 | Sherman Oaks | California | 91403 | Recruiting |
| Sarkis Clinical Trials- Gainesville /ID# 272861 | Gainesville | Florida | 32607 | Recruiting |
| CenExel Hollywood FL /ID# 273101 | Hollywood | Florida | 33024 | Recruiting |
| Accel Research Sites Network - St. Pete /ID# 272962 | Largo | Florida | 33777 | 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 |
| St. Johns Center for Clinical Research - Saint Augustine Location /ID# 279465 | Saint Augustine | Florida | 32086 | Recruiting |
| Neuroscience Institute - West Palm Beach /ID# 272922 | West Palm Beach | Florida | 33407 | Recruiting |
| Georgia Psychiatric Consultants and Advanced Discovery Research /ID# 279438 | Atlanta | Georgia | 30318 | Recruiting |
| Pillar Clinical Research - Chicago /ID# 272823 | Chicago | Illinois | 60641 | Recruiting |
| Amr Conventions Research /ID# 272867 | Warrenville | Illinois | 60555 | Recruiting |
| Saint Charles Psychiatric Associates /ID# 279239 | Saint Charles | Missouri | 63304 | Recruiting |
| Manhattan Behavioral Medicine /ID# 279769 | New York | New York | 10036 | Recruiting |
| University Of Cincinnati Medical Center /ID# 274160 | Cincinnati | Ohio | 45219 | Recruiting |
| The Ohio State University /ID# 272954 | Columbus | Ohio | 43210 | Recruiting |
| Sooner Clinical Research /ID# 272856 | Oklahoma City | Oklahoma | 73116 | Recruiting |
| Community Clinical Research - Cross Park Drive /ID# 272940 | Austin | Texas | 78754 | Recruiting |
| Elixia - Houston /ID# 279200 | Houston | Texas | 77007 | Recruiting |
| Mind Matters Psychiatry /ID# 273536 | Missouri City | Texas | 77459-5204 | Recruiting |
| Pillar Clinical Research - Richardson /ID# 272821 | Richardson | Texas | 75080 | Recruiting |
| Family Psychiatry Of The Woodlands /ID# 275177 | The Woodlands | Texas | 77381 | Recruiting |
| Northwest Clinical Research Center /ID# 272847 | Bellevue | Washington | 98007 | Recruiting |
| Core Clinical Research /ID# 272955 | Everett | Washington | 98201 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06696755, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2026 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06696755 live on ClinicalTrials.gov.