Recruiting

Phase 2

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

Sponsor:

LB Pharmaceuticals Inc.

Code:

NCT07494305

Conditions

Bipolar I Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

LB-102

Placebo

Study Details

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

Study ID

NCT07494305

Start date

Jan 23, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

Interventions

LB-102

N-methyl amisulpride

Placebo

Inactive substance that looks identical to the active treatment

Primary outcome measure

Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10) [ Time Frame: Baseline to Day 42 ]

Central Contacts and Locations

Central contacts

George Nomikos

(212) 605-0300 clinicaltrials@lbpharma.us

Locations

Pillar Clinical Research

Recruiting

Bentonville, Arkansas, United States, 72712

Contacts

Fayz Hudefi, MD

studies@pillarhc.com

Nicole Gutierrez

479-367-2688 ngutierrez@pillarhc.com

Pillar Clinical Research

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Leslie Smith, MD

studies@pillarhc.com

Nicole Gutierrez

501-307-1919 ngutierrez@pillarhc.com

CenExel

Recruiting

Bellflower, California, United States, 90706

Contacts

Maria Nunez Perez

866-478-8391 m.nunezperez@cenexel.com

ProScience Research Group

Recruiting

Culver City, California, United States, 90230

Contacts

Paola Aguirre

424-227-8127 paola.aguirre@proscienceerg.com

CenExel

Recruiting

Garden Grove, California, United States, 922845

Contacts

Dakota Gainers

714-943-5874 d.gainers@cenexel.com

Synergy San Diego

Recruiting

Lemon Grove, California, United States, 91945

Contacts

Corey Weise

619-303-6130 cweise@ergclinical.com

NRC Research Institute

Recruiting

Los Angeles, California, United States, 90015

Contacts

Abigail Parera

213-992-9216 aparera@nrcresearch.com

NRC Research Institute

Recruiting

Orange, California, United States, 92868

Contacts

Abigail Parera

714-943-5874 aparera@nrcresearch.com

CenExel

Recruiting

Riverside, California, United States, 92506

Contacts

Maria Nunez Perez

866-478-2688 m.nunezperez@cenexel.com

CenExel

Recruiting

Torrance, California, United States, 90504

Contacts

844-424-9494 ns.outreach@cenexel.com

St. Jude Clinical Research

Recruiting

Doral, Florida, United States, 33172

Contacts

305-507-2273 slinares@stjudeclinicalresearch.com

Cenexel Hollywood Florida

Recruiting

Hollywood, Florida, United States, 33019

Contacts

Edwin Gomez, MD

954-990-7649 e.gomez@cenexel.com

Ana Molero

954-990-7649 Al.molero@cenexel.com

Innovative Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Melissa Rodco

305-722-8444 mrodco@segaltrials.com

Luis Sotolongo

305-722-8444 lsotolongo@segaltrials.com

Health Synergy Clinical Research

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Katherine Grigelis

561-473-3472 kat@hscresearch.com

Trialmed

Recruiting

Atlanta, Georgia, United States, 30328

Contacts

Jennifer Flemming

678-559-1119 jennifer.flemming@trialmed.com

Cenexel Decatur GA

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Katherine Prowse

404-537-1281 k.prowse@cenexel.com

m.mahathre@cenexel.com

Pillar Clinical Research

Recruiting

Chicago, Illinois, United States, 60641

Contacts

Roueen Rafeyan, MD

224-534-7332 studies@pillarhc.com

Nicole Gutierrez

479-367-2688 ngutierrez@pillarhc.com

NSRT

Recruiting

Detroit, Michigan, United States, 48203

Contacts

Tricia Harrison

248-575-1268 tricia@qcrnetwork.com

Arch Clinical Trials

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Israa Diab

314-266-1243 idiab@archclinicaltrials.com

Redbird Research

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

Haley Lefever

702-577-2000 info@redbird-research.com

Manhattan Behavioral Medicine

Recruiting

New York, New York, United States, 10036

Contacts

Judith Joseph, MD

646-678-4073 joseph@nymbm.com

Neuro-Behavioral Clinical Research

Recruiting

Canton, Ohio, United States, 44720

Contacts

Crystal Blackford

330-493-1118 cblackford@nb-cr.com

Adams Clinical

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Isabel Bear

267-207-2511 ibear@adamsclinical.com

Adams Clinical

Recruiting

DeSoto, Texas, United States, 75115

Contacts

Jaya Koonjbearry

972-283-6286 info@adamsclinical.com

Pillar Clinical Research

Recruiting

Richardson, Texas, United States, 75080

Contacts

Scott Barley, MD

214-396-4844 studies@pillarhc.com

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Contacts

Kimberlee Wheeler

425-453-0404 kwheeler@nwcrc.net

More Information

Sponsor

LB Pharmaceuticals Inc.

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

Bipolar
Major depression episode

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by LB Pharmaceuticals Inc. on 2026-07-27.