Clinical Trial

Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated March 17, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
Summary
Bipolar disorder (BPD) is a chronic debilitating illness characterized by drastic swings in mood, energy and functional ability that affects the adult population. Endoxifen is an active metabolite of the marketed drug Tamoxifen and the present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the Bipolar I disorder patient population compared to a placebo arm. Endoxifen will be compared to a placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is safe and active.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-19.
Status change: Recruiting → Active, Not Recruiting 2025-03-11
Trial Details
NCT Number NCT06608641
Lead Sponsor Jina Pharmaceuticals Inc.
Collaborators: Novum Pharmaceutical Research Services
Conditions Bipolar 1 Disorder
Enrollment 490 participants
Start Date 2024-03-19
Primary Completion 2025-06 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-17