Bipolar I Disorder study: Icalcaprant
Official title A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
ClinicalTrials.gov ID: NCT06696755
What this study is testing
What is Icalcaprant?
This is an investigational oral capsule being studied to treat depressive episodes in adults with bipolar disorder.
Also referred to as ABBV-1354, CVL-354.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the new drug Icalcaprant is safe and if it helps treat depressive episodes in people with bipolar disorder.
- Who it's for
- The study is looking for adults who have been diagnosed with bipolar I or bipolar II disorder.
- What's involved
- Participants will take a daily pill (either the new drug or a sugar pill) and visit a clinic for medical checks, blood tests, and questionnaires.
- Time commitment
- The study lasts 10 weeks, involving 6 weeks of daily treatment followed by a 4-week safety check period.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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...
- 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).
You likely can't join if
- History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same...
- History of or active medical conditions(s) that might interfere with the conduct of the study, confound the interpretation of the study results, or...
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Huntsville, Alabama, United States
- Chandler, Arizona, United States
- Tucson, Arizona, United States
- Bryant, Arkansas, United States
- Anaheim, California, United States
- Garden Grove, California, United States
- Montclair, California, United States
- Oceanside, California, United States
- Orange, California, United States
- Sherman Oaks, California, United States
- Gainesville, Florida, United States
- Hollywood, Florida, United States
- Largo, Florida, United States
- Orlando, Florida, United States
- Pompano Beach, Florida, United States
- Saint Augustine, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Warrenville, Illinois, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Huntsville, Alabama, United States; Chandler, Arizona, United States; Tucson, Arizona, United States; Bryant, Arkansas, United States; Anaheim, California, United States; Garden Grove, California, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.