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Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients

Study on Endoxifen's effects in Bipolar I Disorder patients.

Recruiting
18-65 years
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

Bipolar I Disorder is a serious mental illness that causes extreme mood swings. This study looks at Endoxifen, a drug related to Tamoxifen, to see if it helps people with Bipolar I Disorder. In this study, some participants will get Endoxifen, and others will get a placebo (a pill with no medicine) to compare results. Protein Kinase C (PKC) is a protein in the brain that affects mood, and too much PKC activity can cause bipolar symptoms. Endoxifen might help by reducing PKC activity. The goal is to see if Endoxifen is safe and works well for treating bipolar symptoms.

  • The study requires a 21-day stay in a hospital.
  • Participants must be between 18 and 65 years old.
  • Participants will not receive Endoxifen if they have other serious health issues.
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Study details
    Bipolar 1 Disorder

NCT06608641

Jina Pharmaceuticals Inc.

12 October 2024

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