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Recruiting
NCT07494305
Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
Conditions: Bipolar I Disorder
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 320
Sponsor: LB Pharmaceuticals Inc.
Location: Pillar Clinical Research Bentonville Arkansas
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07494305). StuddyBuddy aggregates publicly available trial information.
