RecruitingBipolar I Disorder

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

Eligible age

18–65 yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

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.

Sponsor: LB Pharmaceuticals Inc.

You may qualify if…

✓ 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

You may not qualify if…

✕ 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.