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RecruitingNCT06696755
A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
Researchers compare two doses of icalcaprant with placebo to find out whether the medicine improves depression symptoms in adults with bipolarity type I or II. Participants take capsules for six weeks while researchers also monitor side effects.
Medication studyAges 18–65United States
Understand this study
What is this study about?
Researchers compare two doses of icalcaprant with placebo to find out whether the medicine improves depression symptoms in adults with bipolarity type I or II. Participants take capsules for six weeks while researchers also monitor side effects.
Who could participate?
This study is for people with bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.
- Listed locations
- Huntsville, United States · Chandler, United States and 30 more locationsSee all locations and recruitment
- Activities
- Medication described in the protocol · Placebo comparator
- Compensation
- Payment and expense reimbursement have not been verified.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
Study start dateStarted: February 3, 2026
- Recruitment status
- Recruiting
- Enrollment listed in the registry
- 195
- Sponsor
- AbbVie
- Sponsor type
- Unknown or unclear
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
- Locations
- United States
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT06696755
- Official title
Show the full 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
Recruitment & locations
RecruitingHuntsville · Chandler · Tucson
29 more locations
- Bryant
- Anaheim
- Garden Grove
- Montclair
- Oceanside
- Orange
- Sherman Oaks
- Gainesville
- Hollywood
- Largo
- Orlando
- Pompano Beach
- Saint Augustine
- West Palm Beach
- Atlanta
- Chicago
- Warrenville
- Saint Charles
- New York
- Cincinnati
- Columbus
- Oklahoma City
- Austin
- Houston
- Missouri City
- Richardson
- The Woodlands
- Bellevue
- Everett
A listed location does not confirm current availability.
Questions about this study
What is this study about?
Researchers compare two doses of icalcaprant with placebo to find out whether the medicine improves depression symptoms in adults with bipolarity type I or II. Participants take capsules for six weeks while researchers also monitor side effects.
Who is behind this study?
The study sponsor is AbbVie.
Does this study involve medication?
Yes. The study involves medication, including Icalcaprant and Placebo for Icalcaprant.
Who can participate?
This study is for people with bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.
Is this study still recruiting?
The registry lists this study as recruiting.
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