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New drug LB-102 aims to lift bipolar depression

NCT ID NCT07494305

Symptom relief Sponsor: LB Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This Phase 2 study tests whether LB-102 can reduce depressive symptoms in adults with bipolar I disorder who are currently in a major depressive episode. About 320 participants will receive either the drug or a placebo for 6 weeks. The main goal is to see if LB-102 improves depression scores more than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LB-102 (N-methyl amisulpride)
What this could lead to
If successful, this could provide a new treatment option for depressive episodes in bipolar I disorder, potentially easing symptoms like low mood and loss of interest.
What could go wrong
This is an early Phase 2 trial with only 320 participants, so results may not confirm effectiveness. The drug may cause side effects or work no better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bipolar I disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar I disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    26 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Adams Clinical

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Adams Clinical

    RECRUITING

    DeSoto, Texas, 75115, United States

    Contact Email: •••••@•••••

  • Arch Clinical Trials

    RECRUITING

    St Louis, Missouri, 63141, United States

  • CenExel

    RECRUITING

    Bellflower, California, 90706, United States

  • CenExel

    RECRUITING

    Garden Grove, California, 922845, United States

  • CenExel

    RECRUITING

    Riverside, California, 92506, United States

  • CenExel

    RECRUITING

    Torrance, California, 90504, United States

  • Cenexel Decatur GA

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Cenexel Hollywood Florida

    RECRUITING

    Hollywood, Florida, 33019, United States

  • Health Synergy Clinical Research

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Innovative Clinical Research

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Manhattan Behavioral Medicine

    RECRUITING

    New York, New York, 10036, United States

  • NRC Research Institute

    RECRUITING

    Los Angeles, California, 90015, United States

  • NRC Research Institute

    RECRUITING

    Orange, California, 92868, United States

  • NSRT

    RECRUITING

    Detroit, Michigan, 48203, United States

  • Neuro-Behavioral Clinical Research

    RECRUITING

    Canton, Ohio, 44720, United States

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Pillar Clinical Research

    RECRUITING

    Bentonville, Arkansas, 72712, United States

    Contact Email: •••••@•••••

  • Pillar Clinical Research

    RECRUITING

    Little Rock, Arkansas, 72204, United States

    Contact Email: •••••@•••••

  • Pillar Clinical Research

    RECRUITING

    Chicago, Illinois, 60641, United States

    Contact Email: •••••@•••••

  • Pillar Clinical Research

    RECRUITING

    Richardson, Texas, 75080, United States

    Contact Email: •••••@•••••

  • ProScience Research Group

    RECRUITING

    Culver City, California, 90230, United States

  • Redbird Research

    RECRUITING

    Las Vegas, Nevada, 89119, United States

    Contact Email: •••••@•••••

  • St. Jude Clinical Research

    RECRUITING

    Doral, Florida, 33172, United States

  • Synergy San Diego

    RECRUITING

    Lemon Grove, California, 91945, United States

  • Trialmed

    RECRUITING

    Atlanta, Georgia, 30328, United States

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