Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
Purpose
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.
Condition
- Bipolar I Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Patients randomized 1:1 to LB-102 or placebo
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Double blind, randomized
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator LB-102 |
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. |
|
|
Placebo Comparator Placebo |
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 |
|
Recruiting Locations
Cenexel Hollywood Florida
Hollywood, Florida 33019
Hollywood, Florida 33019
Cenexel Decatur GA
Decatur, Georgia 30030
Decatur, Georgia 30030
More Details
- Status
- Recruiting
- Sponsor
- LB Pharmaceuticals Inc.
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