Who is eligible for clinical trial NCT06608641?

Participants must meet the protocol's inclusion criteria for Bipolar 1 Disorder. The stated age range is 18 Years to 65 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06608641 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-03-11

Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients (NCT06608641)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Jina Pharmaceuticals Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (40 items).

Location: Synexus — Cerritos, California

Age range: 18 Years to 65 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Male ≥18 to ≤65 years of age and postmenopausal female patients (12 months with no menses without an alternative medical cause) willing to give written informed consent along with at least one first degree relative (the legally acceptable representative \[LAR\]) to participate in the study before initiating any study related procedures.
Six months of spontaneous amenorrhea with serum FSH levels \>40 mIU/mL; OR have had surgical bilateral oophorectomy (with or without hysterectomy) at least six months ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment if she is considered not of child-bearing potential.
Patients must have a diagnosis of bipolar I disorder and currently display an acute manic episode with or without mixed features according to DSM-5 criteria as judged by the Investigator.
Young Mania Rating Scale (YMRS) total score of \> 25 and ≥4 on two of four core items (irritability, speech, content, disruptive/aggressive behavior) at screening and at randomization (baseline). The optimal YMRS23 severity threshold of 25 was chosen as this corresponds to a Positive Predictive Value (PPV) of 83%, signifying that 83% of patients with a baseline score ≥ 25 are at least "Markedly ill".
Score of \>4 in Severity of illness criteria of Clinical Global Impressions- bipolar disorder (CGI-BP) Scale for overall illness at screening and at randomization (baseline).
Ready for voluntary hospitalization (along with the accompanying LAR if required and as advised by the Investigator) for the current manic episode for a minimum of 2 days prior to randomization through 21 days of in-patient treatment period.
Last intake of the medication(s) for BPD should be 2-7 days prior to randomization depending upon the individual drug's plasma half-life.
Patient and / or LAR understand and agree to comply with all the study requirements.
Male patients of child begetting potential must be practicing adequate contraception, and any female partners must agree to the use of, highly effective contraception. Documentation should be provided for surgical sterilization for male patients not of child begetting potential. 11\. Patient has not taken and agrees not to take any medication or therapy prohibited by the protocol (refer to listing in Section 14.7) for the entire study period. 12\. Patients not having any significant diseases or clinically significant abnormal findings except BPD during screening-including medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero- anterior view) recording, etc. which is likely to adversely affect patient\'s safety and may impact the clinical outcome of the study by participating in the study or study objectives in Investigator\'s opinion. 13\. Subjects judged clinically not to be at serious suicide risk, (all responses to the Baseline C-SSRS as "No"), or homicidal risk per clinical questioning.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Newly diagnosed patients not having any suitable treatment exposure in the past for their bipolar mood disorder.
≥ 20% improvement in YMRS total scores between screening and randomization visits.
Patients who meet DSM-5criteria for any psychiatric disorder other than Bipolar I Disorder with Acute manic episodes with or without mixed features
Patients with seizure disorder
Obsessive compulsive disorder or any other co-morbid Axis I anxiety disorder
Patients with borderline or anti-social personality disorder of sufficient current severity to interfere with conduct of the study
Patients with classical premenopausal symptoms were found at risk of developing intolerable hot flushes, irregular vaginal bleeding.
Use of the following medications:
Antihypertensive agents if stable dose has not been administered for at least 1 month before randomization
Antidepressants in the week (or a period of 5 half-lives of the drug) prior to randomization
Continuous daily or standing orders use of benzodiazepines during the month preceding screening (approximately 5 weeks prior to screening)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (12 Sites)

Synexus — Cerritos, California
NRC Research Institute — Los Angeles, California
NRC Research Institute — Orange, California
Medical Research of Westchester, Inc. — Miami, Florida
Sunshine Medical Research Studies Inc. — Miami, Florida
Innovative Clinical Research, Inc. — Miami Lakes, Florida
South Florida Research Phase I-IV, Inc. — Miami Springs, Florida
Santos Research Center, CORP — Tampa, Florida
Accelerated Clinical Trials, LLC — East Point, Georgia
Accelerated Clinical Trials, LLC — Norcross, Georgia
Accelerated Clinical Trials, LLC — Peachtree Corners, Georgia
Precise Research Centers — Flowood, Mississippi

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Bipolar 1 Disorder clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗