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

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.

Eligibility

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

Conditions2

Interventions1

Locations26 sites

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