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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 Sex
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 5308655, Arizona 5551752 85012
Contact:
Study Coordinator
602-562-7000

Noble Clinical Research
Tucson 5318313, Arizona 5551752 85704
Contact:
Study Coordinator
520-612-7860

SanRo Clinical Research Group
Bryant 4103448, Arkansas 4099753 72022
Contact:
Study Coordinator
501-512-2080

Clinical Innovations
Bellflower 5327422, California 5332921 90706
Contact:
Study Coordinator
562-748-8202

Sun Valley Research Center
Imperial 5359052, California 5332921 92251
Contact:
Emilia Alcala
760-545-0123
ealcala@sunvalleyb.com

Sunwise Clinical Research
Lafayette 5364226, California 5332921 94549
Contact:
Study Coordinator
925-298-5147

Synergy San Diego
Lemon Grove 5365893, California 5332921 91945
Contact:
Study Coordinator
619-303-6130

Excell Research
Oceanside 5378771, California 5332921 92056
Contact:
Study Coordinator
760-758-2222

CiTrials
Riverside 5387877, California 5332921 92506
Contact:
Study Coordinator
951-300-4924

Collaborative Neuroscience Research
Torrance 5403022, California 5332921 90504
Contact:
Study Coordinator
310-523-4200

Next Level Clinical Trials
West Covina 5407933, California 5332921 91790
Contact:
Study Coordinator
626-269-8907

MCB Clinical Research Centers
Colorado Springs 5417598, Colorado 5417618 80910
Contact:
Study Coordinator
719-634-6576
sdavis@mcbcrc.com

Clinical Neuroscience Solutions
Jacksonville 4160021, Florida 4155751 32256
Contact:
Study Coordinator
904-281-5757

Accel Clinical
Lakeland 4161438, Florida 4155751 33803
Contact:
Study Coordinator
863-940-2087

Segal Trials
Lauderhill 4161625, Florida 4155751 33319
Contact:
Study Coordinator
954-990-6326

Clinical Neuroscience Solutions
Orlando 4167147, Florida 4155751 32801
Contact:
Study Coordinator
407-425-5100

DMI Research
Pinellas Park 4168630, Florida 4155751 33782
Contact:
Study Coordinator
727-531-2848

Accelerated Enrollment Solutions
Atlanta 4180439, Georgia 4197000 30328
Contact:
Study Coordinator
404-255-6005

Revive Research Institute
Elgin 4890864, Illinois 4896861 60123
Contact:
Study Coordinator
847-497-0421

Tandem Clinical Research
Marrero 4332628, Louisiana 4331987 70072
Contact:
Study Coordinator
504-934-8424

Boston Clinical Trials
Boston 4930956, Massachusetts 6254926 02131
Contact:
Study Coordinator
617-477-4868

Neurobehavioral Medicine Group
Bloomfield Hills 4986429, Michigan 5001836 48302
Contact:
Study Coordinator
248-290-5400

Midwest Research Group
Saint Charles 4406831, Missouri 4398678 63304
Contact:
Study Coordinator
636-946-8032

IMA Clinical Research
Las Vegas 5506956, Nevada 5509151 89102
Contact:
Study Coordinator
702-527-7401

Redbird Research
Las Vegas 5506956, Nevada 5509151 89119
Contact:
Study Coordinator
702-577-2000

Center for Emotional Fitness
Cherry Hill 4501198, New Jersey 5101760 08002
Contact:
Jennifer Mellon
856-857-9500
jmellon@cfef.com

CenExel HRI
Marlton 4502911, New Jersey 5101760 08053
Contact:
Recruitment Director
888-437-4104

IMA Clinical Research
Albuquerque 5454711, New Mexico 5481136 87109
Contact:
Study Coordinator
505-848-3773

Integrative Clinical Trials
Brooklyn 5110302, New York 5128638 11229
Contact:
Study Coordinator
718-444-7774

Pioneer Clinical Research
New York 5128581, New York 5128638 10016
Contact:
Study Coordinator
646-661-4999
mjones@pioneerclinicalny.com

Magnolia Clinical Research
Cary 4459467, North Carolina 4482348 27511
Contact:
Study Coordinator
984-345-3010

UNC Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
Contact:
Study Coordinator
jamie_steed@med.unc.edu

New Hope Clinical Research
Charlotte 4460243, North Carolina 4482348 28211
Contact:
Study Coordinator
980-209-9784

North Star Medical Research
Middleburg Heights 5162851, Ohio 5165418 44130
Contact:
Study Coordinator
440-234-5700

Summit Headlands
Portland 5746545, Oregon 5744337 97210
Contact:
Study Coordinator
503-279-8252

Clinical Neuroscience Solutions
Memphis 4641239, Tennessee 4662168 38119
Contact:
Study Coordinator
901-843-1045

Donald J. Garcia, Jr, MD, PA
Austin 4671654, Texas 4736286 78737
Contact:
Study Coordinator
512-521-0595

Haracec Clinical Research
El Paso 5520993, Texas 4736286 79902
Contact:
Amin Cuevas
amincuevas@medacro.com

R and H Clinical Research
Stafford 4734005, Texas 4736286 77477
Contact:
Study Coordinator
713-367-2791

Grayline Research Center
Wichita Falls 4741752, Texas 4736286 76309
Contact:
Study Coordinator
940-322-1131

Northwest Clinical Research Center
Bellevue 5786882, Washington 5815135 98007
Contact:
Recruitment Coordinator
425-453-0404

Core Clinical Research
Everett 5793933, Washington 5815135 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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