Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
Status:
Recruiting
Trial end date:
2021-05-31
Target enrollment:
Participant gender:
Summary
The present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the study
population. As endoxifen represents a totally new class of drugs in the treatment of the
bipolar disorder, it is essential to compare the drug against placebo to rule out the
psychological influence upon study results. More so given the risks to patients and their
communities from a medication whose efficacy has not been thoroughly evaluated against a
placebo control. Thus, Endoxifen will be compared to 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.
Phase:
Phase 3
Details
Lead Sponsor:
Jina Pharmaceuticals Inc.
Collaborators:
Intas Pharmaceuticals, Ltd. Lambda Therapeutic Research Ltd. Novum Pharmaceutical Research Services