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Active Not RecruitingNCT06608641

Efficacy and Safety of Endoxifen in Bipolarity type I Patients

This study is active but not recruiting. It focuses on bipolarity and currently lists study information in the United States.

BipolarityDrugFrom 18 Years to 65 Years
In plain English

Key information made simple

This study is comparing Endoxifen enteric-coated tablet (8 mg) with placebo for people with Bipolarity type I. Participants receive Endoxifen enteric-coated tablet (8 mg) or placebo and complete study visits and assessments. Some participants may receive placebo instead of the study treatment, and direct benefit is not guaranteed.

What to expect

Your next step

The official record suggests in-person participation through a clinic, with sites including Synexus in Cerritos, NRC Research Institute in Los Angeles, and NRC Research Institute in Orange. Participation appears to involve a study treatment together with follow-up visits and routine safety or progress checks. The main fit is usually matching the main diagnosis, while common reasons not to take part include active substance or alcohol problems that could affect the results and safety concerns that need urgent care first. This is a later-stage study, which usually means a larger group and a closer look at how well the approach holds up.

Public study data

Key study 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
Condition
Bipolar 1 Disorder
Study status
Active Not Recruiting
Phase
Phase 3
Sponsor / lead affiliation
Jina Pharmaceuticals Inc.
Intervention
Endoxifen enteric-coated tablet (8 mg), Placebo Tablets
Location / country
United States
Registry
ClinicalTrials.gov
Why this study may matter

Why this study may matter

This study may matter because it is evaluating Endoxifen enteric-coated tablet (8 mg), Placebo Tablets in a structured research setting. For people exploring bipolarity research, clear information about the goal, status, contacts, and official source can support better questions before any decision.

Before joining

Questions to ask before joining

Official source

Registry reference

This page links back to the public source record so people can verify details directly with the registry and research team.

If you want the full study description, eligibility criteria, locations, and sponsor information in the original format, this is the place to check before taking the next step.

Open source record
Need help deciding?

Ask HopeStage to review this study with me

This form records your interest so HopeStage can follow up with practical guidance. It is not a medical eligibility decision and it does not guarantee a study spot.

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In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular visits and structured follow-up.

Requires travel, with in-person participation in United States.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

Study clarity

Things to check before joining

Sponsor
Jina Pharmaceuticals Inc.
Sponsor type
Other organization
Main activity
medication or study treatment
Intervention
Endoxifen enteric-coated tablet (8 mg), Placebo Tablets
Time commitment
long follow-up or multiple visits
Study phase
Phase 3
Enrollment
Not available
Recruitment status
Active Not Recruiting
Source
Official registry link
FAQ

Questions about this study

What is Efficacy and Safety of Endoxifen in Bipolarity type I Patients?

This study is exploring medication or study treatment for people with bipolarity. Participants may complete study visits, assessments, or follow-up activities defined by the research team. It includes a comparison with placebo. Direct benefit is not guaranteed.

Who is behind this study, and what type of sponsor is it?

This study is sponsored by Jina Pharmaceuticals Inc.. Based on the sponsor name or official registry information, it appears to be another type of organization. You should verify the details in the official registry record.

What does participation involve, what phase is it, and what should I ask about safety?

This study may involve medication or study treatment, study visits, and assessments. The time commitment is long follow-up or multiple visits. The study phase is Phase 3. Earlier-phase studies are often more focused on safety, dose, or feasibility, while later-phase studies usually involve more participants and more information about the intervention. The official source record gives the most accurate details. Enrollment is not available in HopeStage data. HopeStage cannot say whether a study is safe or right for you. Before joining, ask the research team about possible risks, time commitment, visits, side effects, compensation, safety monitoring, and whether participation may affect your current care.

Where can I verify the study details?

Use the official source record linked on this page to check the full study description, recruitment status, eligibility criteria, locations, sponsor information, phase, enrollment, contact details, and any listed risks or requirements.

Efficacy and Safety of Endoxifen in Bipolarity. — Bipolarity Clinical Trial | HopeStage