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NCT06570369 · ClinicalTrials.gov registry record · Phase 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 study of Healthy and Depression, sponsored by Sirtsei Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT06570369: Recruiting Phase 1 study of Healthy and Depression, sponsored by Sirtsei Pharmaceuticals.
NCT06570369 is a Phase 1 study of Healthy and Depression that is actively recruiting participants, run by Sirtsei Pharmaceuticals. The registered enrollment target is 36 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06570369, a Phase 1 study of Healthy and Depression, is actively recruiting participants, sponsored by Sirtsei Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Brain activity using an electroencephalography (EEG) system during rest and while evoking specific brain activity response will be recorded, and artificial intelligence (AI) based analytics will be performed on the EEG recordings to provide a brain network analytic (BNA) profile for each study participant. The BNA profile at the Day 15 Visit will be compared to the BNA profile at Day 1 pre-dose to evaluate changes in the profile after 2 weeks of daily dosing with the assigned study intervention.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SP-624
Study Locations (2)
California
- CenExel CNS - Garden Grove
Nebraska
- Alivation Research - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-08-22 |
| Est. Completion | 2026-04 |
| Phase | Phase 1 |
What NCT06570369 shows while recruiting
NCT06570369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06570369 reports a single indexed study location in California, Nebraska.
Frequently Asked Questions
What is clinical trial NCT06570369 about?
NCT06570369 is a clinical study titled "A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression". 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...
What is the current status of trial NCT06570369?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2024-08-22. Estimated completion is 2026-04.
What conditions does trial NCT06570369 study?
This clinical trial studies the following conditions: Healthy, Depression, Major Depressive Disorder.
What interventions are being tested in trial NCT06570369?
The interventions under investigation include: Placebo (DRUG), SP-624 (DRUG).
Who is sponsoring clinical trial NCT06570369?
This trial is sponsored by Sirtsei Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06570369 being conducted?
This trial has 2 study locations across California, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06570369's enrollment target sits among peer trials
36 595th of 1090 higher than 469 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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