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RecruitingPhase 2

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

LB Pharmaceuticals Inc. · NCT07494305

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
320
US sites recruiting
26
Study start
January 23, 2026
Record last updated
July 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: LB-102; Placebo

Conditions: Bipolar I Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Pillar Clinical Research

    Bentonville, AR 72712

    Site contact: Fayz Hudefi, MD · studies@pillarhc.com

  • Pillar Clinical Research

    Little Rock, AR 72204

    Site contact: Leslie Smith, MD · studies@pillarhc.com

  • CenExel

    Bellflower, CA 90706

    Site contact: Maria Nunez Perez · 866-478-8391 · m.nunezperez@cenexel.com

  • ProScience Research Group

    Culver City, CA 90230

    Site contact: Paola Aguirre · 424-227-8127 · paola.aguirre@proscienceerg.com

  • CenExel

    Garden Grove, CA 922845

    Site contact: Dakota Gainers · 714-943-5874 · d.gainers@cenexel.com

  • Synergy San Diego

    Lemon Grove, CA 91945

    Site contact: Corey Weise · 619-303-6130 · cweise@ergclinical.com

  • NRC Research Institute

    Los Angeles, CA 90015

    Site contact: Abigail Parera · 213-992-9216 · aparera@nrcresearch.com

  • NRC Research Institute

    Orange, CA 92868

    Site contact: Abigail Parera · 714-943-5874 · aparera@nrcresearch.com

  • CenExel

    Riverside, CA 92506

    Site contact: Maria Nunez Perez · 866-478-2688 · m.nunezperez@cenexel.com

  • CenExel

    Torrance, CA 90504

    Site contact: 844-424-9494 · ns.outreach@cenexel.com

  • St. Jude Clinical Research

    Doral, FL 33172

    Site contact: 305-507-2273 · slinares@stjudeclinicalresearch.com

  • Cenexel Hollywood Florida

    Hollywood, FL 33019

    Site contact: Edwin Gomez, MD · 954-990-7649 · e.gomez@cenexel.com

  • Innovative Clinical Research

    Miami Lakes, FL 33016

    Site contact: Melissa Rodco · 305-722-8444 · mrodco@segaltrials.com

  • Health Synergy Clinical Research

    West Palm Beach, FL 33407

    Site contact: Katherine Grigelis · 561-473-3472 · kat@hscresearch.com

  • Trialmed

    Atlanta, GA 30328

    Site contact: Jennifer Flemming · 678-559-1119 · jennifer.flemming@trialmed.com

  • Cenexel Decatur GA

    Decatur, GA 30030

    Site contact: Katherine Prowse · 404-537-1281 · k.prowse@cenexel.com

  • Pillar Clinical Research

    Chicago, IL 60641

    Site contact: Roueen Rafeyan, MD · 224-534-7332 · studies@pillarhc.com

  • NSRT

    Detroit, MI 48203

    Site contact: Tricia Harrison · 248-575-1268 · tricia@qcrnetwork.com

  • Arch Clinical Trials

    St Louis, MO 63141

    Site contact: Israa Diab · 314-266-1243 · idiab@archclinicaltrials.com

  • Redbird Research

    Las Vegas, NV 89119

    Site contact: Haley Lefever · 702-577-2000 · info@redbird-research.com

  • Manhattan Behavioral Medicine

    New York, NY 10036

    Site contact: Judith Joseph, MD · 646-678-4073 · joseph@nymbm.com

  • Neuro-Behavioral Clinical Research

    Canton, OH 44720

    Site contact: Crystal Blackford · 330-493-1118 · cblackford@nb-cr.com

  • Adams Clinical

    Philadelphia, PA 19104

    Site contact: Isabel Bear · 267-207-2511 · ibear@adamsclinical.com

  • Adams Clinical

    DeSoto, TX 75115

    Site contact: Jaya Koonjbearry · 972-283-6286 · info@adamsclinical.com

  • Pillar Clinical Research

    Richardson, TX 75080

    Site contact: Scott Barley, MD · 214-396-4844 · studies@pillarhc.com

  • Northwest Clinical Research Center

    Bellevue, WA 98007

    Site contact: Kimberlee Wheeler · 425-453-0404 · kwheeler@nwcrc.net

Study contacts (from the official record)

  • George Nomikos · (212) 605-0300 · clinicaltrials@lbpharma.us
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