A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
NCT ID: NCT04479852
Last Updated: 2025-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
319 participants
INTERVENTIONAL
2020-09-30
2022-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SP-624
Daily oral capsule, 20 mg/day
SP-624
Oral capsule
Placebo
Daily oral capsule
Placebo
Oral capsule
Interventions
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SP-624
Oral capsule
Placebo
Oral capsule
Eligibility Criteria
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Inclusion Criteria
* Males and females, aged 18 to 65 years
* In generally good physical health
* Body mass index (BMI) must be between 18 and 40 kg/m2
* Females of reproductive potential and males with partners of reproductive potential must agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of study drug
* Subjects must meet criteria for moderate to severe Major Depressive Disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI)
* Willing and able to comply with the study design schedule and other requirements
Exclusion Criteria
* History or presence of any clinically significant medical condition, disease, or surgical history that could jeopardize the safety of the subject or validity of the study data, or interfere with the absorption, distribution, metabolism, or excretion of the study drug
* Failure to discontinue all psychoactive medications or psychoactive supplements including antidepressants and mood stabilizers, within a time period prior to Baseline corresponding to at least five half-lives of the medication in question
* Presence of a clinically significant abnormality on physical examination or electrocardiogram (ECG), including a corrected QT interval using Fridericia's formula (QTcF) \>450 msec for males and \>470 msec for females
* Presence of uncontrolled hypertension, defined as consistent systolic blood pressure (SBP) \>160 mmHg or consistent 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, coagulation, and urinalysis)
* Screening liver function tests (ALT, AST, Alkaline phosphatase) \> 2x the upper limit of normal
* Subjects who, in the opinion of the Investigator, are not suitable candidates for the study
18 Years
65 Years
ALL
No
Sponsors
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Sirtsei Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Greg Rigdon, PhD
Role: STUDY_DIRECTOR
Sirtsei Pharmaceuticals, Inc.
Locations
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Alea Research
Phoenix, Arizona, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Collaborative Neuroscience Research
Garden Grove, California, United States
Pacific Research Partners
Oakland, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Collaborative Neuroscience Research
Torrance, California, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Innovative Clinical Research
Lauderhill, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
iResearch Atlanta
Decatur, Georgia, United States
American Medical Research
Chicago, Illinois, United States
Capstone Clinical Research
Libertyville, Illinois, United States
CBH Health
Gaithersburg, Maryland, United States
Midwest Research Group
Saint Charles, Missouri, United States
Altea Research Institute
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Hassman Research Institute
Marlton, New Jersey, United States
SPRI Clinical Trials
Brooklyn, New York, United States
Manhattan Behavioral Medicine
New York, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
Clinical Trials of America
Hickory, North Carolina, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigations
Portland, Oregon, United States
Oregon Center for Clinical Investigations
Salem, Oregon, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Donald J. Garcia, Jr., MD, PA
Austin, Texas, United States
Future Search Trials of Dallas
Dallas, Texas, United States
Red Oak Psychiatry Associates
Houston, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Core Clinical Research
Everett, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SP-624-201
Identifier Type: -
Identifier Source: org_study_id
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