Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE. (Illuminate1)

May 7, 2026 updated by: LB Pharmaceuticals Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 2, randomized, double blind, placebo controlled, multicenter study designed to assess the efficacy and safety of LB 102 in the treatment of adult patients with major depressive episodes (MDEs) associated with Bipolar I Disorder. Eligible patients will be randomly assigned in a 1:1 ratio to receive LB-102 or placebo as oral administration once daily (QD) treatment for 6 weeks

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
      • Little Rock, Arkansas, United States, 72204
    • California
      • Bellflower, California, United States, 90706
      • Culver City, California, United States, 90230
      • Garden Grove, California, United States, 922845
      • Lemon Grove, California, United States, 91945
      • Los Angeles, California, United States, 90015
        • Recruiting
        • NRC Research Institute
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • NRC Research Institute
        • Contact:
      • Riverside, California, United States, 92506
      • Torrance, California, United States, 90504
    • Florida
      • Doral, Florida, United States, 33172
      • Hollywood, Florida, United States, 33019
      • Miami Lakes, Florida, United States, 33016
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Health Synergy Clinical Research
        • Contact:
    • Georgia
    • Illinois
      • Chicago, Illinois, United States, 60641
    • Michigan
      • Detroit, Michigan, United States, 48203
    • Missouri
      • St Louis, Missouri, United States, 63141
    • Nevada
      • Las Vegas, Nevada, United States, 89119
    • New York
      • New York, New York, United States, 10036
        • Recruiting
        • Manhattan Behavioral Medicine
        • Contact:
    • Ohio
      • Canton, Ohio, United States, 44720
        • Recruiting
        • Neuro-Behavioral Clinical Research
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Adams Clinical
        • Contact:
      • Richardson, Texas, United States, 75080
        • Recruiting
        • Pillar Clinical Research
        • Contact:
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Received electroconvulsive therapy (ECT) within 90 days prior to Screening.
  • Received Transcranial Magnetic Stimulation within 90 days prior to Screening
  • Currently taking prohibited medications as defined in the protocol
  • History of non-response and/or responded only to ketamine, ECT or vagus nerve stimulation
  • Received GLP-1 within 30 of screening
  • History of organ disease that in the opinion of the PI would not make the patient eligible for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LB-102
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
N-methyl amisulpride
Placebo Comparator: Placebo

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
Inactive substance that looks identical to the active treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10)
Time Frame: Baseline to Day 42
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: Baseline to Day 56
Adverse Events (AEs) will be characterized by type, severity, seriousness, and relationship to treatment. All AEs will be coded using the most up-to-date version of the Medical Dictionary for Regulatory Activities (MedDRA). The incidence of AE is the number and percentage of patients reporting the event at least once during the study, and will be counted only once per system organ class (SOC) and preferred term (PT).
Baseline to Day 56
Incidence of Treatment-emergent Mania based on the Young Mania Rating Scale (YMRS) Total Score
Time Frame: Baseline Day 42
The Young Mania Rating Scale is a clinical assessment utilized to assess manic symptoms and their severity. The YMRS consists of 11 items, each focusing on a different aspect of mania. The total score can range from 0 to 60 with higher scores indicating more severe manic symptoms.
Baseline Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LB Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LB-102-011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar I Disorder

Clinical Trials on LB-102

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe