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

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

This is a Phase 2 clinical study evaluating the safety and effectiveness of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.

Key facts

Study ID

NCT04479852

Run by

Sirtsei Pharmaceuticals, Inc.

People needed

319

Starts

2020-09-30

Expected to finish

2022-08-09

Last updated by the study team

2025-06-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide written informed consent to participate in the study
• 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

You may not qualify if…

• Female who is pregnant, breastfeeding, or less than six months postpartum at Screening
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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