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LB-102 for Bipolar I Depression

This study is testing an investigational medication called LB-102 (N-methyl amisulpride) to see if it can help adults with Bipolar I Disorder who are currently experiencing a major depressive episode. You might be able to join if you are between 18 and 65 years old, have a diagnosis of Bipolar I Disorder with a current major depressive episode, and meet other specific health criteria. The study will compare LB-102 to a placebo (an inactive substance that looks the same as the active treatment) to see if LB-102 can reduce depression symptoms. The main way success will be measured is by looking at changes in your depression symptoms over 6 weeks using a specific rating scale. The current recruitment status is unclear, and the study plans to enroll 320 participants.

Study design
This is a Phase 2, randomized, double-blind, placebo-controlled study. Participants will be randomly assigned, like flipping a coin, to receive either LB-102 or a placebo.
What's involved
You would take either LB-102 or placebo once daily for 6 weeks. Your depression symptoms will be measured from the start of the study until Day 42.
Compensation
Not stated in the trial record.
Follow-up
Your depression symptoms will be measured up to Day 42, which is the end of the 6-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07494305

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

Recruiting
PHASE2Ages 18–65InterventionalTreatment
LB Pharmaceuticals Inc.
~320 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:LB-102Placebo

At a glance

Recruiting sites
26 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10)
Measured over Baseline to Day 42

Conditions

Bipolar I Disorder

Explore related trials

Bipolar I disorderUnipolar Depression

Where it's being run

26 sites across 13 states
California8
Florida4
Arkansas2
Georgia2
Texas2
Illinois1
Michigan1
Missouri1

Who to contact

George Nomikos
[email protected]
(212) 605-0300
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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