A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression

Launched by SIRTSEI PHARMACEUTICALS, INC. · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called SP-624 to see how it affects brain activity in both healthy adults and adults with major depression. Researchers want to understand if SP-624 can improve memory and learning in those with depression and to gather information about how safe the drug is. Participants will take either SP-624 or a placebo (a pill with no active ingredients) once a day for two weeks. They will visit the clinic for check-ups and tests at the beginning, after one week, and again at the end of the trial.

To be eligible for this study, participants should be generally healthy and have a body mass index (BMI) between 18 and 40. Adults with major depression should meet specific criteria for moderate to severe symptoms. However, pregnant or breastfeeding women, as well as individuals with significant health issues or certain psychiatric conditions, cannot participate. This trial is currently looking for participants aged 18 to 65, and it offers a chance to contribute to understanding how SP-624 may help improve depression and brain function.

Gender

ALL

Eligibility 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.