LB-102 for adults with Bipolar I major depressive episodes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Pillar Clinical Research
  Bentonville, Arkansas, United States Recruiting
• Pillar Clinical Research
  Little Rock, Arkansas, United States Recruiting
• CenExel
  Bellflower, California, United States Recruiting
• ProScience Research Group
  Culver City, California, United States Recruiting
• CenExel
  Garden Grove, California, United States Recruiting
• Synergy San Diego
  Lemon Grove, California, United States Recruiting

Study contacts

• Study coordinator: George Nomikos
• Email: clinicaltrials@lbpharma.us
• Phone: (212) 605-0300

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SCC Deep Brain Stimulation for Bipolar Depression in Bipolar I Patients

  A small study tests whether deep brain stimulation of the subcallosal cingulate can help people with bipolar I depression who have not improved with other treatments, while monitoring brain signals to watch for manic switches.

  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT07745374

• Comparing an oral crystallized lithium capsule (AL001) with immediate‑release lithium carbonate in adults with Bipolar I Disorder

  This project will test whether a new crystallized lithium capsule called AL001 is as safe and reaches the brain differently than standard immediate‑release lithium carbonate in adults with Bipolar I Disorder.

  Recruiting Phase 1/2 Alzamend Neuro, Inc. · Boston, Massachusetts · NCT07540338

• NBI-1117568 for adults with Bipolar I disorder experiencing current mania

  This trial will test whether NBI-1117568 reduces manic symptoms in adults with Bipolar I disorder who are currently having a manic episode.

  Recruiting at 11 sites Phase 2 Neurocrine Biosciences · Little Rock, Arkansas and 10 other locations · NCT07288320

• Personalized weight-loss medication plan for adults with bipolar disorder

  This pilot tests whether matching FDA-approved weight-loss medicines to specific obesity types helps adults aged 18–65 with bipolar disorder lose weight.

  Recruiting Phase 4 Mayo Clinic · Rochester, Minnesota · NCT07213466

• Monthly subcutaneous long-acting cariprazine injection for adults with schizophrenia, bipolar I disorder, or major depressive disorder.

  This will test a once-a-month subcutaneous long-acting form of cariprazine for adults with schizophrenia, bipolar I disorder, or major depressive disorder who are eligible for the oral medication.

  Recruiting at 6 sites Phase 1/2 Mapi Pharma Ltd. · Ahmedabad and 5 other locations · NCT07185815

• Assessing mental health disorders in Hong Kong using a new recall method

  This study is testing a new way to help people in Hong Kong remember important life events to see how many have experienced major depression and thoughts of suicide.

  Recruiting The University of Hong Kong · Hong Kong · NCT06804525

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.