Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
Public ClinicalTrials.gov record NCT06608641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Oral, Multiple-dose, Parallel, Randomized Study to Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients With Acute Mania Episodes With or Without Mixed Features
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06608641
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 490 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 18, 2024
- Primary completion
- May 31, 2025
- Completion
- Nov 30, 2025
- Last update posted
- Mar 16, 2025
2024 – 2025
United States locations
- U.S. sites
- 12
- U.S. states
- 4
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Synexus | Cerritos | California | 90703 | — |
| NRC Research Institute | Los Angeles | California | 90015 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| Medical Research of Westchester, Inc. | Miami | Florida | 33165 | — |
| Sunshine Medical Research Studies Inc. | Miami | Florida | 33186 | — |
| Innovative Clinical Research, Inc. | Miami Lakes | Florida | 33016 | — |
| South Florida Research Phase I-IV, Inc. | Miami Springs | Florida | 33166 | — |
| Santos Research Center, CORP | Tampa | Florida | 33615 | — |
| Accelerated Clinical Trials, LLC | East Point | Georgia | 30344 | — |
| Accelerated Clinical Trials, LLC | Norcross | Georgia | 30092 | — |
| Accelerated Clinical Trials, LLC | Peachtree Corners | Georgia | 30071 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06608641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 16, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06608641 live on ClinicalTrials.gov.