Oral GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder
UPCOMING STUDY: NOT YET OPEN FOR RECRUITMENT
Study Sponsored by Syndeio Biosciences, Inc
This is a Phase 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose clinical study designed to evaluate the safety and efficacy of GATE-251 versus placebo in subjects with symptoms of Major Depressive Disorder (MDD).
Introduction and Rationale for Study
Depression, also known as Major Depressive Disorder (MDD), is a serious medical illness. It negatively affects how you feel, how you think, and how you act. It is a major global health concern, affecting millions of adults worldwide. While many people find relief with current treatments, a significant number of patients do not respond well enough to the medications currently available.
GATE-251 is a potential new treatment being studied for depression. It is a novel drug that works in the brain to help restore healthy communication between brain cells. Specifically, GATE-251 works on a system in the brain called the NMDAR (a type of receptor): this system is known to be important for how fast-acting antidepressants (like ketamine) work. Early research suggests it may have a low incidence of side effects, which is an important benefit when compared to some currently available treatments.
The purpose of this study is to determine if GATE-251 is safe and effective for people living with Major Depressive Disorder who have not found adequate relief from other treatments.
Purpose and Description
To compare the safety and efficacy of oral GATE-251 versus placebo for reduction of symptoms of major depressive disorder (MDD).
Participation is estimated to last approximately 11 weeks including in-person and virtual visits:
- Screening period & Baseline
- Six weekly Dosing Sessions
- Safety follow-up
Important Considerations
- The study’s procedures are at no cost to the participant.
- Eligible participants will be randomized in a 1:1 ratio to receive GATE-251 or placebo. Participants, research staff, and session monitors are all blinded.
- Eligible participants will taper off of, or discontinue from, all antidepressants as part of their participation in the study. This plan is created with study physician approval and participant safety is monitored. Participants MUST NOT discontinue ANY medication without the physician’s approval. If necessary, the study physician will consult with patients’ providers.
- Participants should not be pregnant, nursing or planning a pregnancy, and must agree to use a highly effective method of birth control during the entire course of the clinical trial.
- Risks to participation will be reviewed extensively during the screening and informed consent process.
- All in person visits take place at Sunstone Therapies.
To express interest in the GATE-251 study, click below:
For more information about the study via the clinicaltrials.gov site, visit: