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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 side effects and effects of Icalcaprant for Bipolar Disorder.

Recruiting
18-65 years
All
Phase 2
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study examines the safety and effectiveness of a new drug called Icalcaprant for treating adults with bipolar I or II disorder. Bipolar disorder is a long-term condition that affects moods, causing mood swings between high energy (mania) and low energy (depression). The study is for adults who are currently experiencing a depressive episode. Participants will be split into three groups, with one group receiving a placebo (a pill with no medicine). The study will last 6 weeks, with an additional 4-week safety follow-up.

During the study, participants will take a daily capsule and visit the hospital or clinic regularly for check-ups. These visits will include medical assessments, blood tests, and questionnaires to track any side effects or changes in mood.

  • Participants will be in the study for a total of 10 weeks (6 weeks treatment + 4 weeks follow-up).
  • Regular hospital or clinic visits are required for monitoring.
  • There may be more work involved than usual care, like extra visits and tests.
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Study details
    Bipolar I Disorder
    Bipolar II Disorder

NCT06696755

AbbVie

17 October 2026

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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.

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

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