Actively Recruiting
A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression
Led by Sirtsei Pharmaceuticals, Inc. · Updated on 2026-03-02
36
Participants Needed
2
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main goal of this clinical trial is to learn if the active study drug (code name: SP-624) has any effect on the electrical activity of the brain in adult healthy volunteers and in adults with major depression. Another goal of the study is to learn if SP-624 improves memory and learning in adults with major depression. The study will also provide additional information on the safety of SP-624 and how well it is tolerated in adult healthy volunteers and adults with major depression. Researchers will compare SP-624 to a placebo (a look-alike substance that contains no drug) to see if SP-624 has any effect on study tests. Study participants will: Take capsules of study drug (SP-624 or a placebo) once daily for 2 weeks; visit the clinic at Screening, Day 1 (first dose of study drug), and Day 15 (last dose of study drug) for checkups and tests; and have phone call check-ups on Day 7 and about 1 week after the last dose of study drug.
CONDITIONS
Official Title
A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be generally in good health
- Have a body mass index (BMI) between 18.0 and 40.0 kg/m2
- Be willing to follow the study requirements
- For participants with depression: have moderate to severe major depressive disorder as defined by the study
You will not qualify if you...
- Be a female who is pregnant or breastfeeding
- Have a clinically significant health condition or abnormal screening test results
- For participants with depression: have co-morbid psychiatric conditions or medication history that exclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
CenExel CNS
Garden Grove, California, United States, 92845
Actively Recruiting
2
Alivation Research
Lincoln, Nebraska, United States, 68526
Completed
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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