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LB-102 for adults with Bipolar I major depressive episodes

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

PHASE2 · LB Pharmaceuticals Inc. · NCT07494305

This trial will test whether taking LB-102 once daily helps adults with Bipolar I disorder who are currently in a major depressive episode, compared with a placebo, over 6 weeks.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorLB Pharmaceuticals Inc. (industry)
Locations26 sites (Bentonville, Arkansas and 25 other locations)
Trial IDNCT07494305 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized, double-blind, placebo-controlled multicenter trial testing oral LB-102 once daily for 6 weeks in adults with Bipolar I disorder experiencing a major depressive episode. Eligible outpatients are randomized 1:1 to receive LB-102 or matching placebo and are monitored for changes in depressive symptoms and safety measures. Key clinical measures include MADRS scores, CGI-BP-S depression ratings, and mania rating scales to ensure mood stability. The protocol requires stability of key baseline scores and central confirmation of diagnosis and episode severity.

Who should consider this trial

Good fit: Adults diagnosed with Bipolar I disorder currently in a nonpsychotic major depressive episode, treated as outpatients, with moderate-to-severe depressive scores (MADRS ≥24) and YMRS ≤12 are the intended participants.

Not a fit: People with psychotic or mixed features, unstable medical conditions, or who cannot meet contraception or outpatient requirements are unlikely to benefit or be eligible for this protocol.

Why it matters

Potential benefit: If successful, LB-102 could reduce depressive symptoms and shorten the time to clinical improvement for adults with Bipolar I depression.

How similar studies have performed: Some approved antipsychotics and adjunctive agents have shown benefit for bipolar depression, but LB-102 is an investigational compound with limited prior clinical data in this condition.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Bentonville, Arkansas and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Bipolar I Disorder, Bipolar, Major depression episode

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.