Bipolar I DisorderPhase 2Illuminate1NCT07494305
Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
A Phase 2 study testing LB-102 in people with Bipolar I Disorder, run by LB Pharmaceuticals Inc. at 26 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- LB-102
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 26 sitesUnited States
- Study dates
- 23 Jan 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
United States26 sites, 26 recruiting
- Recruiting
Trialmed
Atlanta, Georgia, 30328
Jennifer Flemming, 678-559-1119, jennifer.flemming@trialmed.com
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
Kimberlee Wheeler, 425-453-0404, kwheeler@nwcrc.net
- Recruiting
CenExel
Bellflower, California, 90706
Maria Nunez Perez, 866-478-8391 ext. 1319, m.nunezperez@cenexel.com
- Recruiting
Pillar Clinical Research
Bentonville, Arkansas, 72712
Fayz Hudefi, MD, studies@pillarhc.com
Nicole Gutierrez, 479-367-2688, ngutierrez@pillarhc.com
- Recruiting
Neuro-Behavioral Clinical Research
Canton, Ohio, 44720
Crystal Blackford, 330-493-1118, cblackford@nb-cr.com
- Recruiting
Pillar Clinical Research
Chicago, Illinois, 60641
Roueen Rafeyan, MD, 224-534-7332, studies@pillarhc.com
Nicole Gutierrez, 479-367-2688, ngutierrez@pillarhc.com
- Recruiting
ProScience Research Group
Culver City, California, 90230
Paola Aguirre, 424-227-8127 ext. 2, paola.aguirre@proscienceerg.com
- Recruiting
Cenexel Decatur GA
Decatur, Georgia, 30030
Katherine Prowse, 404-537-1281, k.prowse@cenexel.com
m.mahathre@cenexel.com
- Recruiting
Adams Clinical
DeSoto, Texas, 75115
Jaya Koonjbearry, 972-283-6286, info@adamsclinical.com
- Recruiting
NSRT
Detroit, Michigan, 48203
Tricia Harrison, 248-575-1268, tricia@qcrnetwork.com
- Recruiting
St. Jude Clinical Research
Doral, Florida, 33172
305-507-2273, slinares@stjudeclinicalresearch.com
- Recruiting
CenExel
Garden Grove, California, 922845
Dakota Gainers, 714-943-5874, d.gainers@cenexel.com
- Recruiting
Cenexel Hollywood Florida
Hollywood, Florida, 33019
Edwin Gomez, MD, 954-990-7649, e.gomez@cenexel.com
Ana Molero, 954-990-7649, Al.molero@cenexel.com
- Recruiting
Redbird Research
Las Vegas, Nevada, 89119
Haley Lefever, 702-577-2000, info@redbird-research.com
- Recruiting
Synergy San Diego
Lemon Grove, California, 91945
Corey Weise, 619-303-6130, cweise@ergclinical.com
- Recruiting
Pillar Clinical Research
Little Rock, Arkansas, 72204
Leslie Smith, MD, studies@pillarhc.com
Nicole Gutierrez, 501-307-1919, ngutierrez@pillarhc.com
- Recruiting
NRC Research Institute
Los Angeles, California, 90015
Abigail Parera, 213-992-9216, aparera@nrcresearch.com
- Recruiting
Innovative Clinical Research
Miami Lakes, Florida, 33016
Melissa Rodco, 305-722-8444 ext. 6006, mrodco@segaltrials.com
Luis Sotolongo, 305-722-8444 ext. 3611, lsotolongo@segaltrials.com
- Recruiting
Manhattan Behavioral Medicine
New York, New York, 10036
Judith Joseph, MD, 646-678-4073, joseph@nymbm.com
- Recruiting
NRC Research Institute
Orange, California, 92868
Abigail Parera, 714-943-5874, aparera@nrcresearch.com
- Recruiting
Adams Clinical
Philadelphia, Pennsylvania, 19104
Isabel Bear, 267-207-2511, ibear@adamsclinical.com
- Recruiting
Pillar Clinical Research
Richardson, Texas, 75080
Scott Barley, MD, 214-396-4844, studies@pillarhc.com
- Recruiting
CenExel
Riverside, California, 92506
Maria Nunez Perez, 866-478-2688, m.nunezperez@cenexel.com
- Recruiting
Arch Clinical Trials
St Louis, Missouri, 63141
Israa Diab, 314-266-1243, idiab@archclinicaltrials.com
- Recruiting
CenExel
Torrance, California, 90504
844-424-9494, ns.outreach@cenexel.com
- Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, 33407
Katherine Grigelis, 561-473-3472, kat@hscresearch.com
About this study
Official title: 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
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.
Read the detailed description
This is a Phase 2, randomized, double blind, placebo controlled, multicenter study designed to assess the efficacy and safety of LB 102 in the treatment of adult patients with major depressive episodes (MDEs) associated with Bipolar I Disorder. Eligible patients will be randomly assigned in a 1:1 ratio to receive LB-102 or placebo as oral administration once daily (QD) treatment for 6 weeks
- Conditions
- Bipolar I Disorder
- Being tested
- LB-102, Placebo
- Keywords
- Bipolar, Major depression episode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-102Drug
N-methyl amisulpride
PlaceboOther
Inactive substance that looks identical to the active treatment
| Study group | Role | What they receive |
|---|---|---|
| LB-102 | Active comparator | Patients will be randomized 1:1 to either active drug (LB-102) or Placebo. Dosing of LB-102 will start at 25 mg QD fixed dose for the first 3 weeks. At the start of Week 4, the dose of LB-102 may be increased to 50 mg QD based on the Clinical Global Impression Scale, Bipolar Version (CGI BP) improvement score. Receives: Drug: LB-102 |
| Placebo | Placebo comparator | Patients will be randomized 1:1 to either LB-102 or placebo. Those patients on placebo will take one table QD for the length (6 weeks) of the clinical study. Patients will receive a new bottle of medication each week. Patients and PI, study staff will be blinded to which treatment (LB-102 or placebo), patients are randomized to.
Patients will restart antidepressant or mood stabilizer treatment (if applicable) after the last dose of the study treatment on study day 43 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Measured: Baseline to Day 42
Secondary outcomes (2)
Incidence of Adverse Events
Adverse Events (AEs) will be characterized by type, severity, seriousness, and relationship to treatment. All AEs will be coded using the most up-to-date version of the Medical Dictionary for Regulatory Activities (MedDRA). The incidence of AE is the number and percentage of patients reporting the event at least once during the study, and will be counted only once per system organ class (SOC) and preferred term (PT).
Measured: Baseline to Day 56
Incidence of Treatment-emergent Mania based on the Young Mania Rating Scale (YMRS) Total Score
The Young Mania Rating Scale is a clinical assessment utilized to assess manic symptoms and their severity. The YMRS consists of 11 items, each focusing on a different aspect of mania. The total score can range from 0 to 60 with higher scores indicating more severe manic symptoms.
Measured: Baseline Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start23 Jan 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized 1:1 to LB-102 or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LB Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494305
- Sponsor's protocol ID
- LB-102-011
- Acronym
- Illuminate1
- Status last verified
- Jul 2026
- First submitted
- 26 Dec 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07494305
- Acronym / sponsor ID
- Illuminate1 / LB-102-011
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar, Major depression episode
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- LB Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 2, randomized, double blind, placebo controlled, multicenter study designed to assess the efficacy and safety of LB 102 in the treatment of adult patients with major depressive episodes (MDEs) associated with Bipolar I Disorder. Eligible patients will be randomly assigned in a 1:1 ratio to receive LB-102 or placebo as oral administration once daily (QD) treatment for 6 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients randomized 1:1 to LB-102 or placebo
| Arm | Type | Receives |
|---|---|---|
| LB-102 | Active comparator | Drug: LB-102Patients will be randomized 1:1 to either active drug (LB-102) or Placebo. Dosing of LB-102 will start at 25 mg QD fixed dose for the first 3 weeks. At the start of Week 4, the dose of LB-102 may be increased to 50 mg QD based on the Clinical Global Impression Scale, Bipolar Version (CGI BP) improvement score. |
| Placebo | Placebo comparator | Other: PlaceboPatients will be randomized 1:1 to either LB-102 or placebo. Those patients on placebo will take one table QD for the length (6 weeks) of the clinical study. Patients will receive a new bottle of medication each week. Patients and PI, study staff will be blinded to which treatment (LB-102 or placebo), patients are randomized to. Patients will restart antidepressant or mood stabilizer treatment (if applicable) after the last dose of the study treatment on study day 43 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LB-102N-methyl amisulpride | Drug | LB-102 |
| PlaceboInactive substance that looks identical to the active treatment | Other | Placebo |
Primary outcome
Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10)
Time frame: Baseline to Day 42
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
2 secondary outcomes
Incidence of Adverse Events
Time frame: Baseline to Day 56
Incidence of Treatment-emergent Mania based on the Young Mania Rating Scale (YMRS) Total Score
Time frame: Baseline Day 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LB-102 in people with Bipolar I Disorder, run by LB Pharmaceuticals Inc. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George Nomikos ((212) 605-0300, clinicaltrials@lbpharma.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10) (time frame: Baseline to Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.