NCT07494305 · LB Pharmaceuticals Inc.
Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
(Illuminate1)
What this study is about
Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomly assigned (like flipping a coin) to either active drug (LB-102 or placebo). Treatment is for 6 weeks.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Bentonville, Arkansas
- Little Rock, Arkansas
- Bellflower, California
- Culver City, California
- Garden Grove, California
- Lemon Grove, California
- Los Angeles, California
- Orange, California
- Riverside, California
- Torrance, California
- Doral, Florida
- Hollywood, Florida
And 14 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations