RecruitingPhase 2NCT07494305

Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.

A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Major Depressive Episodes Associated With Bipolar I Disorder


Sponsor

LB Pharmaceuticals Inc.

Enrollment

320 participants

Start Date

Jan 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either active drug (LB-102 or placebo). Treatment is for 6 weeks.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called LB-102 and Placebo for people with bipolar i disorder. The study is currently recruiting participants at 26 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLB-102

N-methyl amisulpride

OTHERPlacebo

Inactive substance that looks identical to the active treatment


Locations(26)

Pillar Clinical Research

Bentonville, Arkansas, United States

Pillar Clinical Research

Little Rock, Arkansas, United States

CenExel

Bellflower, California, United States

ProScience Research Group

Culver City, California, United States

CenExel

Garden Grove, California, United States

Synergy San Diego

Lemon Grove, California, United States

NRC Research Institute

Los Angeles, California, United States

NRC Research Institute

Orange, California, United States

CenExel

Riverside, California, United States

CenExel

Torrance, California, United States

St. Jude Clinical Research

Doral, Florida, United States

Cenexel Hollywood Florida

Hollywood, Florida, United States

Innovative Clinical Research

Miami Lakes, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

Trialmed

Atlanta, Georgia, United States

Cenexel Decatur GA

Decatur, Georgia, United States

Pillar Clinical Research

Chicago, Illinois, United States

NSRT

Detroit, Michigan, United States

Arch Clinical Trials

St Louis, Missouri, United States

Redbird Research

Las Vegas, Nevada, United States

Manhattan Behavioral Medicine

New York, New York, United States

Neuro-Behavioral Clinical Research

Canton, Ohio, United States

Adams Clinical

Philadelphia, Pennsylvania, United States

Adams Clinical

DeSoto, Texas, United States

Pillar Clinical Research

Richardson, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07494305


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