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Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients

NCT04315792 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-09-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Endoxifen

Administration of Endoxifen for 3 weeks

DRUG

Placebo oral tablet

Administration of Placebo for 3 weeks

Sponsors & Collaborators

  • Novum Pharmaceutical Research Services

    collaborator INDUSTRY

  • Lambda Therapeutic Research Ltd.

    collaborator INDUSTRY

  • Jina Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Theodore R Treese, MD · Innovative Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2021-01-25
Completion
2021-08-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04315792 on ClinicalTrials.gov