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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

Study on oral Icalcaprant's effects in adults with Bipolar I/II.

Recruiting
18-65 years
All
Phase 2

This study is about testing a new drug, Icalcaprant, to see if it's safe and works well for adults with bipolar disorder. Bipolar disorder is a condition where people have extreme mood changes. The study will involve about 195 adults from across the U.S.

Participants will take Icalcaprant or a placebo (a pill that doesn't have any medicine) once a day for 6 weeks. After that, there will be a follow-up for 4 weeks to check safety. A placebo is used to compare if the drug is really working. The study will have regular check-ups, blood tests, and questionnaires to see how the drug affects the participants.

  • The study lasts for about 10 weeks, including the follow-up period.
  • Participants will need to visit a hospital or clinic regularly for check-ups.
  • There's a chance of experiencing more side effects compared to usual care.
Study details
    Bipolar I Disorder
    Bipolar II Disorder

NCT06696755

AbbVie

18 April 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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