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Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients

Exploring Endoxifen for Bipolar I Disorder: A Clinical Trial Study

Recruiting
18-65 years
All
Phase 3

Bipolar disorder (BPD) is a long-term illness with big mood swings. Endoxifen is a special chemical made from the drug Tamoxifen. This study looks at how safe and helpful 8 mg of Endoxifen is for people with Bipolar I Disorder. Patients will receive Endoxifen or a placebo (a pill with no active drug) to see if Endoxifen works better than the placebo. Protein Kinase C (PKC) is involved in brain communication and sometimes gets overactive in people with bipolar disorder. Endoxifen helps by stopping too much PKC activity. The study focuses on reducing symptoms quickly and keeping patients feeling better over time.

  • The study involves a 21-day in-patient treatment period.
  • Participants must be hospitalized for at least 2 days before randomization.
  • Both safety and efficacy of Endoxifen will be compared with a placebo.

People aged 18-65 with Bipolar I Disorder can join if they meet specific health criteria. Those with other major health issues or recent drug trial participation cannot join. Participants should avoid certain medications and agree to follow study rules.

Study details
    Bipolar 1 Disorder

NCT06608641

Jina Pharmaceuticals Inc.

12 October 2024

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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

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

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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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