Your session is about to expire
← Back to Search
Selective Estrogen Receptor Modulator
Endoxifen for Bipolar Disorder
Phase 3
Recruiting
Research Sponsored by Jina Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must meet specific criteria for diagnosis of bipolar I disorder and display acute manic episode with or without mixed features
Male patients aged ≥18 to ≤65 years or postmenopausal female patients willing to give written informed consent
Must not have
Patients with seizure disorder, obsessive compulsive disorder, or other co-morbid anxiety disorders
Patients with coagulation disorders, venous thromboembolism history, or retinal pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 34 days
Awards & highlights
Pivotal Trial
Summary
This trial aims to test the effectiveness and safety of an 8 mg dose of Endoxifen in Bipolar I disorder patients compared to a placebo. The goal is to show that Endoxifen works
Who is the study for?
This trial is for adults with Bipolar I Disorder, a condition causing extreme mood swings. Participants must meet specific health criteria to join but details are not provided here.
What is being tested?
The study tests the effectiveness and safety of an 8 mg endoxifen tablet against a placebo in managing symptoms of Bipolar I Disorder. Endoxifen is derived from Tamoxifen, which is already on the market.
What are the potential side effects?
Potential side effects are not detailed here, but as with any medication, they may include reactions at varying degrees of severity and could affect different body systems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with bipolar I disorder and am currently experiencing a manic episode.
Select...
I am a man aged 18-65 or a postmenopausal woman and agree to participate.
Select...
My scores on the YMRS and CGI-BP scales meet the trial's requirements.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a seizure disorder, OCD, or another anxiety disorder.
Select...
I have a blood clotting disorder, history of blood clots, or eye retina issues.
Select...
I am not taking any medications that are not allowed in the study.
Select...
I have certain blood test abnormalities or heart conditions.
Select...
I have a history of substance abuse or certain cancers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 34 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~34 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy
Secondary study objectives
Safety
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Endoxifen ArmExperimental Treatment1 Intervention
Endoxifen enteric-coated tablet (8 mg). Patients will continue treatment with their initial randomized medication for 3 weeks
Group II: Placebo ArmPlacebo Group1 Intervention
Placebo tablets. Patients will continue administration with their initial randomized medication for 3 weeks
Find a Location
Who is running the clinical trial?
Jina Pharmaceuticals Inc.Lead Sponsor
3 Previous Clinical Trials
794 Total Patients Enrolled
Novum Pharmaceutical Research ServicesIndustry Sponsor
16 Previous Clinical Trials
6,085 Total Patients Enrolled