LB-102 for Bipolar Disorder
(Illuminate1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LB-102 or placebo as oral administration once daily for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LB-102
- Placebo
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
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.
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
LB Pharmaceuticals Inc.
Lead Sponsor
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