Active, Not Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID06254612

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

Led by Sirtsei Pharmaceuticals, Inc. · Updated on 2026-05-15

456

Participants Needed

50

Research Sites

N/A

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

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Key

  • 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

Not Eligible

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).

Trial Site Locations

Total: 50 locations

1

IMA Clinical Research

Phoenix, Arizona, United States, 85012

Status Unknown

2

Noble Clinical Research

Tucson, Arizona, United States, 85704

Status Unknown

3

SanRo Clinical Research Group

Bryant, Arkansas, United States, 72022

Status Unknown

4

Clinical Innovations

Bellflower, California, United States, 90706

Status Unknown

5

Sun Valley Research Center

Imperial, California, United States, 92251

Status Unknown

6

Synergy San Diego

Lemon Grove, California, United States, 91945

Status Unknown

7

Excell Research

Oceanside, California, United States, 92056

Status Unknown

8

CiTrials

Riverside, California, United States, 92506

Status Unknown

9

Collaborative Neuroscience Research

Torrance, California, United States, 90504

Status Unknown

10

Sunwise Clinical Research

Walnut Creek, California, United States, 94596

Status Unknown

11

Next Level Clinical Trials

West Covina, California, United States, 91790

Status Unknown

12

MCB Clinical Research Centers

Colorado Springs, Colorado, United States, 80910

Status Unknown

13

Clinical Neuroscience Solutions

Jacksonville, Florida, United States, 32256

Status Unknown

14

Accel Clinical

Lakeland, Florida, United States, 33803

Status Unknown

15

Segal Trials

Lauderhill, Florida, United States, 33319

Status Unknown

16

Segal Trials - Miami Lakes

Miami Lakes, Florida, United States, 33016

Status Unknown

17

Clinical Neuroscience Solutions

Orlando, Florida, United States, 32801

Status Unknown

18

DMI Research

Pinellas Park, Florida, United States, 33782

Status Unknown

19

Accelerated Enrollment Solutions

Atlanta, Georgia, United States, 30328

Status Unknown

20

Velocity Clinical Research

Meridian, Idaho, United States, 83642

Status Unknown

21

Revive Research Institute

Elgin, Illinois, United States, 60123

Status Unknown

22

Tandem Clinical Research

Marrero, Louisiana, United States, 70072

Status Unknown

23

Boston Clinical Trials

Boston, Massachusetts, United States, 02131

Status Unknown

24

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States, 48302

Status Unknown

25

Midwest Research Group

Saint Charles, Missouri, United States, 63304

Status Unknown

26

Alivation Research

Lincoln, Nebraska, United States, 68526

Status Unknown

27

IMA Clinical Research

Las Vegas, Nevada, United States, 89102

Status Unknown

28

Redbird Research

Las Vegas, Nevada, United States, 89119

Status Unknown

29

Center for Emotional Fitness

Cherry Hill, New Jersey, United States, 08002

Status Unknown

30

CenExel HRI

Marlton, New Jersey, United States, 08053

Status Unknown

31

IMA Clinical Research

Albuquerque, New Mexico, United States, 87109

Status Unknown

32

Integrative Clinical Trials

Brooklyn, New York, United States, 11229

Status Unknown

33

Pioneer Clinical Research

New York, New York, United States, 10016

Status Unknown

34

Magnolia Clinical Research

Cary, North Carolina, United States, 27511

Status Unknown

35

UNC Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Status Unknown

36

New Hope Clinical Research

Charlotte, North Carolina, United States, 28211

Status Unknown

37

Velocity Clinical Research

Beachwood, Ohio, United States, 44122

Status Unknown

38

Midwest Clinical Research Center

Dayton, Ohio, United States, 45417

Status Unknown

39

North Star Medical Research

Middleburg Heights, Ohio, United States, 44130

Status Unknown

40

Summit Headlands

Portland, Oregon, United States, 97210

Status Unknown

41

Coastal Carolina Research Center

North Charleston, South Carolina, United States, 29405

Status Unknown

42

Clinical Neuroscience Solutions

Memphis, Tennessee, United States, 38119

Status Unknown

43

Donald J. Garcia, Jr, MD, PA

Austin, Texas, United States, 78737

Status Unknown

44

Future Search Trials of Dallas

Dallas, Texas, United States, 75231

Status Unknown

45

Haracec Clinical Research

El Paso, Texas, United States, 79902

Status Unknown

46

Pillar Clinical Research

Richardson, Texas, United States, 75080

Status Unknown

47

R and H Clinical Research

Stafford, Texas, United States, 77477

Status Unknown

48

Grayline Research Center

Wichita Falls, Texas, United States, 76309

Status Unknown

49

Northwest Clinical Research Center

Bellevue, Washington, United States, 98007

Status Unknown

50

Core Clinical Research

Everett, Washington, United States, 98201

Status Unknown

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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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Published Research Related To This Trial

A phase 2, multicenter, double-blind, randomized, placebo-controlled study of the safety and efficacy of forvisirvat (SP-624) in the treatment of adults with major depressive disorder.

Joel Raskin, Anita H Clayton, Susan G Kornstein...

https://pubmed.ncbi.nlm.nih.gov/41099447