RecruitingPhase 2NCT06254612

A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

A Multi-center, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

Sponsor

Sirtsei Pharmaceuticals, Inc.

Enrollment

456 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

Summary

This is a Phase 2B clinical study evaluating the effectiveness and safety of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial tests SP-624, a new investigational drug, for treating moderate to severe major depressive disorder (MDD) — clinical depression. It is an early-phase study assessing whether the drug is safe and effective in adults who meet the clinical definition of MDD. **You may be eligible if...** - You are aged 18–65 with a confirmed diagnosis of moderate to severe major depressive disorder (MDD) - You are in generally good physical health - Your BMI is between 18 and 45 **You may NOT be eligible if...** - You are pregnant, breastfeeding, or less than 6 months postpartum - You have a history of psychosis, schizophrenia, bipolar disorder, or personality disorder - You have significant heart disease (coronary artery disease, heart failure, valve disease, etc.) - You have a history of suicidal behavior or current serious suicide risk - You are taking medications that interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSP-624

Once daily oral administration of two capsules totaling 20 mg/day

DRUGPlacebo

Once daily oral administration of two matching placebo capsules

Locations(50)

IMA Clinical Research

Phoenix, Arizona, United States

Noble Clinical Research

Tucson, Arizona, United States

SanRo Clinical Research Group

Bryant, Arkansas, United States

Clinical Innovations

Bellflower, California, United States

Sun Valley Research Center

Imperial, California, United States

Synergy San Diego

Lemon Grove, California, United States

Excell Research

Oceanside, California, United States

CiTrials

Riverside, California, United States

Collaborative Neuroscience Research

Torrance, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

Next Level Clinical Trials

West Covina, California, United States

MCB Clinical Research Centers

Colorado Springs, Colorado, United States

Clinical Neuroscience Solutions

Jacksonville, Florida, United States

Accel Clinical

Lakeland, Florida, United States

Segal Trials

Lauderhill, Florida, United States

Segal Trials - Miami Lakes

Miami Lakes, Florida, United States

Clinical Neuroscience Solutions

Orlando, Florida, United States

DMI Research

Pinellas Park, Florida, United States

Accelerated Enrollment Solutions

Atlanta, Georgia, United States

Velocity Clinical Research

Meridian, Idaho, United States

Revive Research Institute

Elgin, Illinois, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

Midwest Research Group

Saint Charles, Missouri, United States

Alivation Research

Lincoln, Nebraska, United States

IMA Clinical Research

Las Vegas, Nevada, United States

Redbird Research

Las Vegas, Nevada, United States

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

CenExel HRI

Marlton, New Jersey, United States

IMA Clinical Research

Albuquerque, New Mexico, United States

Integrative Clinical Trials

Brooklyn, New York, United States

Pioneer Clinical Research

New York, New York, United States

Magnolia Clinical Research

Cary, North Carolina, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

Velocity Clinical Research

Beachwood, Ohio, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

North Star Medical Research

Middleburg Heights, Ohio, United States

Summit Headlands

Portland, Oregon, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Clinical Neuroscience Solutions

Memphis, Tennessee, United States

Donald J. Garcia, Jr, MD, PA

Austin, Texas, United States

Future Search Trials of Dallas

Dallas, Texas, United States

Haracec Clinical Research

El Paso, Texas, United States

Pillar Clinical Research

Richardson, Texas, United States

R and H Clinical Research

Stafford, Texas, United States

Grayline Research Center

Wichita Falls, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Core Clinical Research

Everett, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06254612

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A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(50)

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