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

NCT07494305 | Recruiting Phase 2 FDA Drug

• 1 other identifier: LB-102-011
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 26

Brief 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

Bipolar I Disorder

Keywords

Bipolar; Major depression episode

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10)

  The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.

  Baseline to Day 42

Secondary Outcomes (2)

• Incidence of Adverse Events

  Baseline to Day 56

• Incidence of Treatment-emergent Mania based on the Young Mania Rating Scale (YMRS) Total Score

  Baseline Day 42

Study Arms (2)

LB-102

ACTIVE COMPARATOR

Patients will be randomized 1:1 to either active drug (LB-102) or Placebo. Dosing of LB-102 will start at 25 mg QD fixed dose for the first 3 weeks. At the start of Week 4, the dose of LB-102 may be increased to 50 mg QD based on the Clinical Global Impression Scale, Bipolar Version (CGI BP) improvement score.

Drug: LB-102

Placebo

PLACEBO COMPARATOR

Patients will be randomized 1:1 to either LB-102 or placebo. Those patients on placebo will take one table QD for the length (6 weeks) of the clinical study. Patients will receive a new bottle of medication each week. Patients and PI, study staff will be blinded to which treatment (LB-102 or placebo), patients are randomized to. Patients will restart antidepressant or mood stabilizer treatment (if applicable) after the last dose of the study treatment on study day 43

Other: Placebo

Interventions

LB-102 DRUG

N-methyl amisulpride

LB-102

Placebo OTHER

Inactive substance that looks identical to the active treatment

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign IRB approved ICF, Stable living environment
• Diagnosis of Bipolar1 disorder defined by criteria in the DSM 5 and currently experiencing a MDE without psychotic or mixed features, and supported by the SCID 5 CT
• Currently experiencing an MDE that began at least 4 weeks but no more than 18 months prior to randomization
• Currently treated in an out-patient environment
• MADRS 10 total score ≥24 at both Screening and Baseline with a difference of \<20% in scores between visits.
• Clinical Global Impression Scale, Bipolar Version Severity of Illness scale (CGI BP S) depression score ≥4 at both Screening and Baseline.
• YMRS total score ≤12 at both Screening and Baseline.
• Good physical health
• BMI of ≥18 and ≤40 kg/m2.
• Eligibility confirmed centrally for the severity, diagnosis, and treatment history by the SAFER interview.

You may not qualify if:

• Sexually active woman of childbearing potential and male who are not practicing 2 different methods of birth control or woman who is currently breast feeding
• History of non-response to 2 adequate medication trials for depressive symptoms
• Improvement of ≥20% in MADRS 10 total score between the screening and baseline assessments
• Have bipolar disorder with mixed features or considered as rapid cyclers
• Plan to initiate formal cognitive or behavioral therapy, systematic psychotherapy during the study, or plan to initiate such therapy during the study
• History of disorders other than bipolar disorder, confirmed by previous psychiatric evaluation or the DSM 5 within 12 months prior to Screening
• Experience of hallucinations, delusions, or any other psychotic symptomatology in the current MDE attributable to a primary DSM 5 diagnosis other than bipolar disorder.
• Hospitalized for mania associated with Bipolar I Disorder within 30 days prior to Screening. Any previous manic phase must have completely resolved before enrollment in the study.
• Significant risk for suicidal behavior during the study as determined by the Investigator's clinical assessment
• Hypo or hyperthyroidism
• Insulin dependent diabetes
• Uncontrolled hypertension
• Known significant cardiac disease
• Laboratory results outside the defined protocol ranges
• Clinically significant abnormal ECG findings

Sponsors & Collaborators

• LB Pharmaceuticals Inc.: lead

Study Sites (26)

Pillar Clinical Research

Bentonville, Arkansas, 72712, United States

RECRUITING

Pillar Clinical Research

Little Rock, Arkansas, 72204, United States

RECRUITING

CenExel

Bellflower, California, 90706, United States

RECRUITING

ProScience Research Group

Culver City, California, 90230, United States

RECRUITING

CenExel

Garden Grove, California, 922845, United States

RECRUITING

Synergy San Diego

Lemon Grove, California, 91945, United States

RECRUITING

NRC Research Institute

Los Angeles, California, 90015, United States

RECRUITING

NRC Research Institute

Orange, California, 92868, United States

RECRUITING

CenExel

Riverside, California, 92506, United States

RECRUITING

CenExel

Torrance, California, 90504, United States

RECRUITING

St. Jude Clinical Research

Doral, Florida, 33172, United States

RECRUITING

Cenexel Hollywood Florida

Hollywood, Florida, 33019, United States

RECRUITING

Innovative Clinical Research

Miami Lakes, Florida, 33016, United States

RECRUITING

Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States

RECRUITING

Trialmed

Atlanta, Georgia, 30328, United States

RECRUITING

Cenexel Decatur GA

Decatur, Georgia, 30030, United States

RECRUITING

Pillar Clinical Research

Chicago, Illinois, 60641, United States

RECRUITING

NSRT

Detroit, Michigan, 48203, United States

RECRUITING

Arch Clinical Trials

St Louis, Missouri, 63141, United States

RECRUITING

Redbird Research

Las Vegas, Nevada, 89119, United States

RECRUITING

Manhattan Behavioral Medicine

New York, New York, 10036, United States

RECRUITING

Neuro-Behavioral Clinical Research

Canton, Ohio, 44720, United States

RECRUITING

Adams Clinical

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Adams Clinical

DeSoto, Texas, 75115, United States

RECRUITING

Pillar Clinical Research

Richardson, Texas, 75080, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

Central Study Contacts

Anna Eramo

CONTACT

(212) 605-0300; clinicaltrials@lbpharma.us

George Nomikos

CONTACT

(212) 605-0300; clinicaltrials@lbpharma.us

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind, randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients randomized 1:1 to LB-102 or placebo

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: March 27, 2026
• Study Start: January 23, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (26)