Actively Recruiting
Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
Led by LB Pharmaceuticals Inc. · Updated on 2026-05-11
320
Participants Needed
26
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed IRB approved informed consent form and stable living environment
- Diagnosis of Bipolar I Disorder per DSM 5 criteria with current major depressive episode without psychotic or mixed features confirmed by SCID 5 CT
- Current major depressive episode started at least 4 weeks and no more than 18 months before randomization
- Receiving treatment in an outpatient setting
- MADRS 10 total score of 24 or higher at Screening and Baseline with less than 20% difference between visits
- Clinical Global Impression Bipolar Severity of Illness depression score of 4 or higher at Screening and Baseline
- Young Mania Rating Scale total score of 12 or lower at Screening and Baseline
- Good physical health
- Body mass index between 18 and 40 kg/m2
- Severity, diagnosis, and treatment history confirmed centrally by SAFER interview
You will not qualify if you...
- Sexually active women of childbearing potential and males not using two different methods of birth control, or breastfeeding women
- History of non-response to two adequate medication trials for depressive symptoms
- Improvement of 20% or more in MADRS 10 total score between Screening and Baseline
- Bipolar disorder with mixed features or rapid cycling
- Plans to start formal cognitive or behavioral therapy or systematic psychotherapy during the study
- History of psychiatric disorders other than bipolar disorder within 12 months prior to Screening
- Current experience of hallucinations, delusions, or psychotic symptoms from a diagnosis other than bipolar disorder
- Hospitalization for mania associated with Bipolar I Disorder within 30 days before Screening
- Significant risk for suicidal behavior as assessed by the Investigator
- Hypothyroidism or hyperthyroidism
- Insulin-dependent diabetes
- Uncontrolled hypertension
- Known significant heart disease
- Laboratory results outside protocol-defined ranges
- Clinically significant abnormal ECG findings
- Electroconvulsive therapy within 90 days before Screening
- Transcranial Magnetic Stimulation within 90 days before Screening
- Taking prohibited medications as defined in the protocol
- History of non-response or response only to ketamine, ECT, or vagus nerve stimulation
- Received GLP-1 treatment within 30 days of Screening
- History of organ disease considered exclusionary by the Principal Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 26 locations
1
Pillar Clinical Research
Bentonville, Arkansas, United States, 72712
Actively Recruiting
2
Pillar Clinical Research
Little Rock, Arkansas, United States, 72204
Actively Recruiting
3
CenExel
Bellflower, California, United States, 90706
Actively Recruiting
4
ProScience Research Group
Culver City, California, United States, 90230
Actively Recruiting
5
CenExel
Garden Grove, California, United States, 922845
Actively Recruiting
6
Synergy San Diego
Lemon Grove, California, United States, 91945
Actively Recruiting
7
NRC Research Institute
Los Angeles, California, United States, 90015
Actively Recruiting
8
NRC Research Institute
Orange, California, United States, 92868
Actively Recruiting
9
CenExel
Riverside, California, United States, 92506
Actively Recruiting
10
CenExel
Torrance, California, United States, 90504
Actively Recruiting
11
St. Jude Clinical Research
Doral, Florida, United States, 33172
Actively Recruiting
12
Cenexel Hollywood Florida
Hollywood, Florida, United States, 33019
Actively Recruiting
13
Innovative Clinical Research
Miami Lakes, Florida, United States, 33016
Actively Recruiting
14
Health Synergy Clinical Research
West Palm Beach, Florida, United States, 33407
Actively Recruiting
15
Trialmed
Atlanta, Georgia, United States, 30328
Actively Recruiting
16
Cenexel Decatur GA
Decatur, Georgia, United States, 30030
Actively Recruiting
17
Pillar Clinical Research
Chicago, Illinois, United States, 60641
Actively Recruiting
18
NSRT
Detroit, Michigan, United States, 48203
Actively Recruiting
19
Arch Clinical Trials
St Louis, Missouri, United States, 63141
Actively Recruiting
20
Redbird Research
Las Vegas, Nevada, United States, 89119
Actively Recruiting
21
Manhattan Behavioral Medicine
New York, New York, United States, 10036
Actively Recruiting
22
Neuro-Behavioral Clinical Research
Canton, Ohio, United States, 44720
Actively Recruiting
23
Adams Clinical
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
24
Adams Clinical
DeSoto, Texas, United States, 75115
Actively Recruiting
25
Pillar Clinical Research
Richardson, Texas, United States, 75080
Actively Recruiting
26
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
Research Team
A
Anna Eramo
CONTACT
G
George Nomikos
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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