320 Participants NeededMy employer runs this trial

LB-102 for Bipolar Disorder

(Illuminate1 Trial)

Recruiting at 26 trial locations
AE
GN
Overseen ByGeorge Nomikos
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, LB-102, for individuals with Bipolar 1 Disorder experiencing a major depressive episode. The goal is to determine if LB-102 can alleviate depression symptoms more effectively than a placebo, which resembles the real drug but contains no active ingredients. Participants will take either LB-102 or a placebo for six weeks. The trial seeks individuals who have experienced a depressive episode for at least four weeks. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications, but it mentions that certain medications are prohibited. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that LB-102 is likely to be safe for humans?

Research has shown that LB-102 is generally safe and well-tolerated in people. In earlier studies, participants reported only minimal weight gain, a common concern with similar treatments. A few individuals experienced side effects related to prolactin, a hormone, but such cases were rare. Overall, LB-102 demonstrated a strong safety record with low rates of movement-related side effects. These findings suggest that LB-102 could be a promising treatment for conditions like bipolar disorder, with manageable safety concerns.12345

Why do researchers think this study treatment might be promising for bipolar disorder?

Unlike standard treatments for bipolar disorder, which typically include mood stabilizers like lithium and anticonvulsants, LB-102 works differently. It is a new compound that might modulate neurotransmitter systems in a novel way, potentially offering a fresh approach to managing bipolar symptoms. Researchers are excited because LB-102 could provide more effective symptom control with fewer side effects than existing medications, which often have challenging side effects. This could mean improved quality of life for patients and a significant advancement in bipolar disorder treatment options.

What evidence suggests that LB-102 might be an effective treatment for Bipolar Disorder?

This trial will compare LB-102 with a placebo for treating bipolar depression. Research has shown that LB-102 may help treat this condition. In a recent study, patients taking LB-102 improved more than those taking a placebo. Another study found that it significantly reduced symptoms, suggesting its potential usefulness for mood disorders. LB-102 has also demonstrated strong effects in treating schizophrenia, indicating it might help manage symptoms of bipolar disorder. Overall, early evidence suggests LB-102 could be an effective treatment for bipolar depression.12678

Are You a Good Fit for This Trial?

This trial is for adults with Bipolar 1 Disorder who are currently having a major depressive episode (not mixed or psychotic), have stable living situations, good physical health, and meet certain depression severity scores. They must be outpatients and their current episode started between 4 weeks and 18 months ago.

Inclusion Criteria

* MADRS 10 total score ≥24 at both Screening and Baseline with a difference of \<20% in scores between visits.
* Sign IRB approved ICF, Stable living environment
* BMI of ≥18 and ≤40 kg/m2.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LB-102 or placebo as oral administration once daily for 6 weeks

6 weeks
Weekly visits for medication dispensing

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
1-2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • LB-102
  • Placebo

Trial Overview

The study tests the effectiveness and safety of a new drug called LB-102 compared to a placebo in treating depression in people with Bipolar 1 Disorder. Participants are randomly assigned to receive either LB-102 or placebo for six weeks.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: LB-102Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

LB Pharmaceuticals Inc.

Lead Sponsor

Trials
3
Recruited
430+

Citations

Antipsychotic Efficacy and Safety of LB-102 in the Treatment of ...

LB-102 100 mg treatment resulted in a significant LS mean (SE) change from baseline to week 4 in PANSS total score of −16.1 (1.91; P = .002 vs ...

Phase 2 Trial Initiated: LB-102 for Bipolar Depression

In January 2025, investigators shared positive data from a 4-week placebo-controlled, double-blinded, phase 2 trial in participants with acute ...

Pipeline

It is designed to evaluate the efficacy and safety of two doses (25 mg and 50 mg given once daily) of LB-102 for the treatment of bipolar depression. The two- ...

NCT07363577 | Study to Evaluate LB-102 for the ...

This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus ...

LB Pharmaceuticals Announces Publication in JAMA ...

In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with ...

N-methyl amisulpride (LB-102) Clinical Study Report ...

STUDY DESIGN: This was a Phase 1, randomized double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and PK of LB-102 in ...

LB Pharmaceuticals Presents New Analysis from the ...

LB-102 was generally safe and well tolerated, exhibiting a potentially class-leading safety profile with low rates of extrapyramidal ...

PET clinical study of novel antipsychotic LB-102 ...

LB-102 was generally safe and well-tolerated at all doses. Results of this study were used to inform dosing in a subsequent Phase 2 clinical ...