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NCT06254612 | RECRUITING | Major Depressive Disorder

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

Sirtsei Pharmaceuticals, Inc.

Brief 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.

Condition or disease

Major Depressive Disorder

Intervention/treatment

SP-624

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 456 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-03-25
Estimated Primary Completion Date : 2025-09-30
Estimated Study Completion Date : 2025-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • * Males and females, aged 18 to 65 years, inclusive.
  • * Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI).
  • * In generally good physical health, in the opinion of the Investigator.
  • * Body mass index (BMI) must be ≥ 18 and ≤ 45 kg/m2.
  • Key Exclusion Criteria
    • * Female who is pregnant, breastfeeding, or less than 6 months postpartum at screen.
    • * A history of or current DSM-5 diagnosis of MDD with psychotic features, any schizophrenia spectrum and other psychotic disorders, bipolar disorder, or personality disorder.
    • * Presence or history of any known clinically significant cardiovascular disorders including, but not limited to: coronary artery disease, heart failure, valvular heart disease, cardiomyopathies, myocardial infarction, chamber enlargement or hypertrophy, or orthostatic hypotension.
    • * Presence of uncontrolled hypertension, defined as consistent sitting systolic blood pressure (SBP) \>160 mmHg or consistent sitting diastolic blood pressure (DBP) \>95 mmHg despite present therapy.
    • * Screening laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the Investigator (clinical chemistry, hematology, thyroid function, and urinalysis).
A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

Location Details

NCT06254612

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How to Participate

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Locations

RECRUITING

United States, Arizona

IMA Clinical Research

Phoenix, arizona, United States, 85012

RECRUITING

United States, Arkansas

SanRo Clinical Research Group

Bryant, arkansas, United States, 72022

RECRUITING

United States, California

Clinical Innovations

Bellflower, California, United States, 90706

RECRUITING

United States, California

Sun Valley Research Center

Imperial, California, United States, 92251

RECRUITING

United States, California

Sunwise Clinical Research

Lafayette, California, United States, 94549

RECRUITING

United States, California

Synergy San Diego

Lemon Grove, California, United States, 91945

RECRUITING

United States, California

Excell Research

Oceanside, California, United States, 92056

RECRUITING

United States, California

CiTrials

Riverside, California, United States, 92506

RECRUITING

United States, California

Collaborative Neuroscience Research

Torrance, California, United States, 90504

RECRUITING

United States, California

Next Level Clinical Trials

West Covina, California, United States, 91790

RECRUITING

United States, Colorado

MCB Clinical Research Centers

Colorado Springs, Colorado, United States, 80910

RECRUITING

United States, Florida

Clinical Neuroscience Solutions

Jacksonville, florida, United States, 32256

RECRUITING

United States, Florida

Accel Clinical

Lakeland, florida, United States, 33803

RECRUITING

United States, Florida

Segal Trials

Lauderhill, florida, United States, 33319

RECRUITING

United States, Florida

Segal Trials - Miami Lakes

Miami Lakes, florida, United States, 33016

RECRUITING

United States, Florida

Clinical Neuroscience Solutions

Orlando, florida, United States, 32801

RECRUITING

United States, Florida

DMI Research

Pinellas Park, florida, United States, 33782

RECRUITING

United States, Georgia

Accelerated Enrollment Solutions

Atlanta, Georgia, United States, 30328

RECRUITING

United States, Idaho

Velocity Clinical Research

Meridian, Idaho, United States, 83642

RECRUITING

United States, Illinois

Revive Research Institute

Elgin, Illinois, United States, 60123

RECRUITING

United States, Massachusetts

Boston Clinical Trials

Boston, Massachusetts, United States, 02131

RECRUITING

United States, Nebraska

Alivation Research

Lincoln, Nebraska, United States, 68526

RECRUITING

United States, Nevada

IMA Clinical Research

vegas, Nevada, United States, 89102

RECRUITING

United States, New Jersey

CenExel HRI

Berlin, New Jersey, United States, 08009

RECRUITING

United States, New Jersey

Center for Emotional Fitness

Cherry Hill, New Jersey, United States, 08002

RECRUITING

United States, New Mexico

IMA Clinical Research

Albuquerque, New Mexico, United States, 87109

RECRUITING

United States, New York

Integrative Clinical Trials

Brooklyn, New York, United States, 11229

RECRUITING

United States, North Carolina

UNC Chapel Hill

Chapel Hill, North Carolina, United States, 27599

RECRUITING

United States, North Carolina

New Hope Clinical Research

Charlotte, North Carolina, United States, 28211

RECRUITING

United States, Ohio

Velocity Clinical Research

Beachwood, Ohio, United States, 44122

RECRUITING

United States, Ohio

Midwest Clinical Research Center

Dayton, Ohio, United States, 45417

RECRUITING

United States, Oregon

Summit Headlands

Portland, Oregon, United States, 97210

RECRUITING

United States, South Carolina

Coastal Carolina Research Center

North Charleston, South Carolina, United States, 29405

RECRUITING

United States, Tennessee

Clinical Neuroscience Solutions

Memphis, Tennessee, United States, 38119

RECRUITING

United States, Texas

Donald J. Garcia, Jr., MD, PA

Austin, Texas, United States, 78737

RECRUITING

United States, Texas

Future Search Trials of Dallas

dallas, Texas, United States, 75231

RECRUITING

United States, Texas

Haracec Clinical Research

The Pass, Texas, United States, 79902

RECRUITING

United States, Texas

Pillar Clinical Research

Richardson, Texas, United States, 75080

RECRUITING

United States, Texas

R and H Clinical Research

Stafford, Texas, United States, 77477

RECRUITING

United States, Texas

Grayline Research Center

Wichita Falls, Texas, United States, 76309

RECRUITING

United States, Washington

Core Clinical Research

Everett, Washington, United States, 98201