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

NCT07494305 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

LB-102

N-methyl amisulpride

OTHER

Placebo

Inactive substance that looks identical to the active treatment

Sponsors & Collaborators

  • LB Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-01-23
Primary Completion
2028-02-29
Completion
2028-02-29
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 NCT07494305 on ClinicalTrials.gov