Exploring the effects of SP-624 on brain activity in healthy adults and those 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
This study is testing if the drug SP-624 can change brain activity and improve memory and learning in both healthy adults and those with major depression.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sirtsei Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 2 sites (Garden Grove, California and 1 other locations) |
| Trial ID | NCT06570369 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the effects of the drug SP-624 on brain electrical activity in both healthy adults and adults diagnosed with major depressive disorder. Participants will take either SP-624 or a placebo daily for two weeks, with assessments conducted at the start and end of the treatment period. The study will also evaluate the drug's impact on memory and learning, as well as its safety and tolerability. Participants will undergo clinic visits and phone check-ups to monitor their health throughout the study.
Who should consider this trial
Good fit: Ideal candidates include healthy adults and adults with moderate to severe major depressive disorder who meet specific health criteria.
Not a fit: Patients with significant health conditions or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for individuals suffering from major depression.
How similar studies have performed: While this approach is novel, similar studies exploring brain activity and depression treatments have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * Female who is pregnant or breastfeeding. * 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.
Where this trial is running
Garden Grove, California and 1 other locations
- CenExel CNS — Garden Grove, California, United States (Recruiting)
- Alivation Research — Lincoln, Nebraska, United States (Completed)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.