RECRUITING

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

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Conditions

Major Depressive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-03-25
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06254612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females, aged 18 to 65 years, inclusive.
  2. * Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI).
  3. * In generally good physical health, in the opinion of the Investigator.
  4. * Body mass index (BMI) must be ≥ 18 and ≤ 45 kg/m2.
  1. * Female who is pregnant, breastfeeding, or less than 6 months postpartum at screen.
  2. * 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.
  3. * 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.
  4. * 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.
  5. * 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).

Contacts and Locations

Study Contact

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

Principal Investigator

Greg Rigdon, PhD
STUDY_DIRECTOR
Sirtsei Pharmaceuticals, Inc.

Study Locations (Sites)

IMA Clinical Research
Phoenix, Arizona, 85012
United States
Noble Clinical Research
Tucson, Arizona, 85704
United States
SanRo Clinical Research Group
Bryant, Arkansas, 72022
United States
Clinical Innovations
Bellflower, California, 90706
United States
Sun Valley Research Center
Imperial, California, 92251
United States
Sunwise Clinical Research
Lafayette, California, 94549
United States
Synergy San Diego
Lemon Grove, California, 91945
United States
Excell Research
Oceanside, California, 92056
United States
CiTrials
Riverside, California, 92506
United States
Collaborative Neuroscience Research
Torrance, California, 90504
United States
Next Level Clinical Trials
West Covina, California, 91790
United States
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910
United States
Clinical Neuroscience Solutions
Jacksonville, Florida, 32256
United States
Accel Clinical
Lakeland, Florida, 33803
United States
Segal Trials
Lauderhill, Florida, 33319
United States
Segal Trials - Miami Lakes
Miami Lakes, Florida, 33016
United States
Clinical Neuroscience Solutions
Orlando, Florida, 32801
United States
DMI Research
Pinellas Park, Florida, 33782
United States
Accelerated Enrollment Solutions
Atlanta, Georgia, 30328
United States
Velocity Clinical Research
Meridian, Idaho, 83642
United States
Revive Research Institute
Elgin, Illinois, 60123
United States
Tandem Clinical Research
Marrero, Louisiana, 70072
United States
Boston Clinical Trials
Boston, Massachusetts, 02131
United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
United States
Midwest Research Group
Saint Charles, Missouri, 63304
United States
Alivation Research
Lincoln, Nebraska, 68526
United States
IMA Clinical Research
Las Vegas, Nevada, 89102
United States
Redbird Research
Las Vegas, Nevada, 89119
United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
United States
CenExel HRI
Marlton, New Jersey, 08053
United States
IMA Clinical Research
Albuquerque, New Mexico, 87109
United States
Integrative Clinical Trials
Brooklyn, New York, 11229
United States
Pioneer Clinical Research
New York, New York, 10016
United States
Magnolia Clinical Research
Cary, North Carolina, 27511
United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
United States
New Hope Clinical Research
Charlotte, North Carolina, 28211
United States
Velocity Clinical Research
Beachwood, Ohio, 44122
United States
Midwest Clinical Research Center
Dayton, Ohio, 45417
United States
North Star Medical Research
Middleburg Heights, Ohio, 44130
United States
Summit Headlands
Portland, Oregon, 97210
United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
United States
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119
United States
Donald J. Garcia, Jr, MD, PA
Austin, Texas, 78737
United States
Future Search Trials of Dallas
Dallas, Texas, 75231
United States
Haracec Clinical Research
El Paso, Texas, 79902
United States
Pillar Clinical Research
Richardson, Texas, 75080
United States
R and H Clinical Research
Stafford, Texas, 77477
United States
Grayline Research Center
Wichita Falls, Texas, 76309
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
United States
Core Clinical Research
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: Sirtsei Pharmaceuticals, Inc.

  • Greg Rigdon, PhD, STUDY_DIRECTOR, Sirtsei Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-25
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2024-03-25
Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder