Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

490

Participants

Timeline

Start Date

March 19, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Bipolar 1 Disorder
Interventions
DRUG

Endoxifen enteric-coated tablet (8 mg)

Patients will continue treatment with their initial randomized medication for 3 weeks

DRUG

Placebo Tablets

Patients will be treated with Endoxifen Placebo Tablets for 21 days

Trial Locations (12)

30071

Accelerated Clinical Trials, LLC, Peachtree Corners

30092

Accelerated Clinical Trials, LLC, Norcross

30344

Accelerated Clinical Trials, LLC, East Point

33016

Innovative Clinical Research, Inc., Miami Lakes

33165

Medical Research of Westchester, Inc., Miami

33166

South Florida Research Phase I-IV, Inc., Miami Springs

33186

Sunshine Medical Research Studies Inc., Miami

33615

Santos Research Center, CORP, Tampa

39232

Precise Research Centers, Flowood

90015

NRC Research Institute, Los Angeles

90703

Synexus, Cerritos

92868

NRC Research Institute, Orange

All Listed Sponsors
collaborator

Novum Pharmaceutical Research Services

INDUSTRY

lead

Jina Pharmaceuticals Inc.

INDUSTRY