Actively Recruiting
A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
Led by Sirtsei Pharmaceuticals, Inc. · Updated on 2026-04-01
456
Participants Needed
50
Research Sites
118 weeks
Total Duration
On this page
Sponsors
S
Sirtsei Pharmaceuticals, Inc.
Lead Sponsor
R
Rho, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 �3E= 18 and �3C= 45 kg/m2.
You will not qualify if you...
- 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).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 50 locations
1
IMA Clinical Research
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
Noble Clinical Research
Tucson, Arizona, United States, 85704
Actively Recruiting
3
SanRo Clinical Research Group
Bryant, Arkansas, United States, 72022
Actively Recruiting
4
Clinical Innovations
Bellflower, California, United States, 90706
Actively Recruiting
5
Sun Valley Research Center
Imperial, California, United States, 92251
Actively Recruiting
6
Synergy San Diego
Lemon Grove, California, United States, 91945
Actively Recruiting
7
Excell Research
Oceanside, California, United States, 92056
Actively Recruiting
8
CiTrials
Riverside, California, United States, 92506
Actively Recruiting
9
Collaborative Neuroscience Research
Torrance, California, United States, 90504
Actively Recruiting
10
Sunwise Clinical Research
Walnut Creek, California, United States, 94596
Actively Recruiting
11
Next Level Clinical Trials
West Covina, California, United States, 91790
Actively Recruiting
12
MCB Clinical Research Centers
Colorado Springs, Colorado, United States, 80910
Actively Recruiting
13
Clinical Neuroscience Solutions
Jacksonville, Florida, United States, 32256
Actively Recruiting
14
Accel Clinical
Lakeland, Florida, United States, 33803
Completed
15
Segal Trials
Lauderhill, Florida, United States, 33319
Actively Recruiting
16
Segal Trials - Miami Lakes
Miami Lakes, Florida, United States, 33016
Completed
17
Clinical Neuroscience Solutions
Orlando, Florida, United States, 32801
Actively Recruiting
18
DMI Research
Pinellas Park, Florida, United States, 33782
Actively Recruiting
19
Accelerated Enrollment Solutions
Atlanta, Georgia, United States, 30328
Actively Recruiting
20
Velocity Clinical Research
Meridian, Idaho, United States, 83642
Completed
21
Revive Research Institute
Elgin, Illinois, United States, 60123
Actively Recruiting
22
Tandem Clinical Research
Marrero, Louisiana, United States, 70072
Actively Recruiting
23
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
Actively Recruiting
24
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States, 48302
Actively Recruiting
25
Midwest Research Group
Saint Charles, Missouri, United States, 63304
Actively Recruiting
26
Alivation Research
Lincoln, Nebraska, United States, 68526
Completed
27
IMA Clinical Research
Las Vegas, Nevada, United States, 89102
Actively Recruiting
28
Redbird Research
Las Vegas, Nevada, United States, 89119
Actively Recruiting
29
Center for Emotional Fitness
Cherry Hill, New Jersey, United States, 08002
Actively Recruiting
30
CenExel HRI
Marlton, New Jersey, United States, 08053
Active, Not Recruiting
31
IMA Clinical Research
Albuquerque, New Mexico, United States, 87109
Completed
32
Integrative Clinical Trials
Brooklyn, New York, United States, 11229
Actively Recruiting
33
Pioneer Clinical Research
New York, New York, United States, 10016
Actively Recruiting
34
Magnolia Clinical Research
Cary, North Carolina, United States, 27511
Actively Recruiting
35
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
36
New Hope Clinical Research
Charlotte, North Carolina, United States, 28211
Actively Recruiting
37
Velocity Clinical Research
Beachwood, Ohio, United States, 44122
Completed
38
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
Completed
39
North Star Medical Research
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
40
Summit Headlands
Portland, Oregon, United States, 97210
Actively Recruiting
41
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
Completed
42
Clinical Neuroscience Solutions
Memphis, Tennessee, United States, 38119
Actively Recruiting
43
Donald J. Garcia, Jr, MD, PA
Austin, Texas, United States, 78737
Actively Recruiting
44
Future Search Trials of Dallas
Dallas, Texas, United States, 75231
Completed
45
Haracec Clinical Research
El Paso, Texas, United States, 79902
Actively Recruiting
46
Pillar Clinical Research
Richardson, Texas, United States, 75080
Completed
47
R and H Clinical Research
Stafford, Texas, United States, 77477
Actively Recruiting
48
Grayline Research Center
Wichita Falls, Texas, United States, 76309
Actively Recruiting
49
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
50
Core Clinical Research
Everett, Washington, United States, 98201
Actively Recruiting
Research Team
Y
Yuki Prescott
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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