Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients

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.

Timeline

Start

2020-08-03

Primary completion

2021-01-25

Completion

2021-08-25

Drugs

Indications