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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SP-624 		Participants to receive two 10 mg capsules of SP-624 once daily for a total daily dose of 20 mg
  • Drug: SP-624
    Once daily oral administration of two capsules totaling 20 mg/day
Placebo Comparator
Placebo 		Participant to receive 2 matching placebo capsules once daily
  • Drug: Placebo
    Once daily oral administration of two matching placebo capsules

Recruiting Locations

IMA Clinical Research
Phoenix, Arizona 85012
Contact:
Study Coordinator
602-562-7000

SanRo Clinical Research Group
Bryant, Arkansas 72022
Contact:
Study Coordinator
501-512-2080

Clinical Innovations
Bellflower, California 90706
Contact:
Study Coordinator
562-748-8202

Sun Valley Research Center
Imperial, California 92251
Contact:
Emilia Alcala
760-545-0123
ealcala@sunvalleyb.com

Sunwise Clinical Research
Lafayette, California 94549
Contact:
Study Coordinator
925-298-5147

Synergy San Diego
Lemon Grove, California 91945
Contact:
Study Coordinator
619-303-6130

Excell Research
Oceanside, California 92056
Contact:
Study Coordinator
760-758-2222

CiTrials
Riverside, California 92506
Contact:
Study Coordinator
951-300-4924

Collaborative Neuroscience Research
Torrance, California 90504
Contact:
Study Coordinator
310-523-4200

Next Level Clinical Trials
West Covina, California 91790
Contact:
Study Coordinator
626-269-8907

MCB Clinical Research Centers
Colorado Springs, Colorado 80910
Contact:
Study Coordinator
719-634-6576
sdavis@mcbcrc.com

Clinical Neuroscience Solutions
Jacksonville, Florida 32256
Contact:
Study Coordinator
904-281-5757

Accel Clinical
Lakeland, Florida 33803
Contact:
Study Coordinator
863-940-2087

Segal Trials
Lauderhill, Florida 33319
Contact:
Study Coordinator
954-990-6326

Clinical Neuroscience Solutions
Orlando, Florida 32801
Contact:
Study Coordinator
407-425-5100

DMI Research
Pinellas Park, Florida 33782
Contact:
Study Coordinator
727-531-2848

Accelerated Enrollment Solutions
Atlanta, Georgia 30328
Contact:
Study Coordinator
404-255-6005

Velocity Clinical Research
Meridian, Idaho 83642
Contact:
Study Coordinator
208-377-8653

Revive Research Institute
Elgin, Illinois 60123
Contact:
Study Coordinator
847-497-0421

Boston Clinical Trials
Boston, Massachusetts 02131
Contact:
Study Coordinator
617-477-4868

Alivation Research
Lincoln, Nebraska 68526
Contact:
Grant Wessel
gwessel@alivation.com

IMA Clinical Research
Las Vegas, Nevada 89102
Contact:
Study Coordinator
702-527-7401

Center for Emotional Fitness
Cherry Hill, New Jersey 08002
Contact:
Jennifer Mellon
856-857-9500
jmellon@cfef.com

CenExel HRI
Marlton, New Jersey 08053
Contact:
Recruitment Director
888-437-4104

IMA Clinical Research
Albuquerque, New Mexico 87109
Contact:
Study Coordinator
505-848-3773

Integrative Clinical Trials
Brooklyn, New York 11229
Contact:
Study Coordinator
718-444-7774

Pioneer Clinical Research
New York, New York 10016
Contact:
Study Coordinator
646-661-4999
mjones@pioneerclinicalny.com

Magnolia Clinical Research
Cary, North Carolina 27511
Contact:
Study Coordinator
984-345-3010

UNC Chapel Hill
Chapel Hill, North Carolina 27599
Contact:
Study Coordinator
jamie_steed@med.unc.edu

New Hope Clinical Research
Charlotte, North Carolina 28211
Contact:
Study Coordinator
980-209-9784

North Star Medical Research
Middleburg Heights, Ohio 44130
Contact:
Study Coordinator
440-234-5700

Summit Headlands
Portland, Oregon 97210
Contact:
Study Coordinator
503-279-8252

Coastal Carolina Research Center
North Charleston, South Carolina 29405
Contact:
Study Coordinator
843-856-3784

Clinical Neuroscience Solutions
Memphis, Tennessee 38119
Contact:
Study Coordinator
901-843-1045

Donald J. Garcia, Jr, MD, PA
Austin, Texas 78737
Contact:
Study Coordinator
512-521-0595

Future Search Trials of Dallas
Dallas, Texas 75231
Contact:
Study Coordinator
214-369-2600

Haracec Clinical Research
El Paso, Texas 79902
Contact:
Shaundi Brakefield
719-757-5552
shaundibrakefield@medacro.com

Pillar Clinical Research
Richardson, Texas 75080
Contact:
Study Coordinator
214-396-4844

R and H Clinical Research
Stafford, Texas 77477
Contact:
Study Coordinator
713-367-2791

Grayline Research Center
Wichita Falls, Texas 76309
Contact:
Study Coordinator
940-322-1131

Core Clinical Research
Everett, Washington 98201
Contact:
Study Coordinator
425-443-9551

More Details

NCT ID
NCT06254612
Status
Recruiting
Sponsor
Sirtsei Pharmaceuticals, Inc.

Study Contact

Yuki Prescott
919-460-9500
yprescott@arrivobio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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