Bipolar I Disorder
Conditions
Keywords
Bipolar, Major depression episode
Brief 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.
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
Interventions
DRUGLB-102
N-methyl amisulpride
OTHERPlacebo
Inactive substance that looks identical to the active treatment
Sponsors
LB Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind, randomized
Intervention model description
Patients randomized 1:1 to LB-102 or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | Baseline to Day 56 | 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). |
| Incidence of Treatment-emergent Mania based on the Young Mania Rating Scale (YMRS) Total Score | Baseline Day 42 | 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. |
Countries
United States
Contacts
CONTACTGeorge Nomikos
Outcome results
None listed