NCT06570369CompletedPhase 1
A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression
A Phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled Study to Explore the Effect of SP-624 on Brain Network Analytics in Cohorts of Healthy Adult Subjects and Subjects With Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 17 Aug 2024
- Start date
- 22 Aug 2024
- Primary completion date
- 11 May 2026
- Lead sponsor
- Sirtsei Pharmaceuticals, Inc.
- Diseases
- Depression
- NCT number
- NCT06570369
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 26
- From 22 Aug 2024 to the primary completion date, 11 May 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clinically significant health condition or clinically significant abnormal results on screening health tests
- For participants with depression: presence of exclusionary study criteria for co-morbid psychiatric conditions or medication history.
Other
- Female who is pregnant or breastfeeding.
Who the study is looking for
- In generally good health
- Body mass index (BMI) between 18.0 and 40.0 kg/m2
- Willing to comply with the requirements of the study
- For participants with depression: must meet study criteria for moderate to severe major depressive disorder
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CenExel CNS Coordinator of this site? Confirm its status | Garden Grove | United States | Unknown status |
| Alivation Research Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.