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

Conditions

• Bipolar I Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• LB-102 — DRUG
  N-methyl amisulpride
• Placebo — OTHER
  Inactive substance that looks identical to the active treatment

Study Details

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.

Key Dates

Start date

Jan 23, 2026

Status verified

May 2026

Primary completion

Feb 29, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10) [ Time Frame: Baseline to Day 42 ]

Central Contacts

• Anna Eramo
  (212) 605-0300
  [email protected]
• George Nomikos
  (212) 605-0300
  [email protected]

Locations (26)

Find similar trials in Bentonville, AR

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