A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression
NCT Number: NCT06570369
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Major Depressive Disorder|Depression|Healthy
Interventions: DRUG: SP-624|DRUG: Placebo
Sponsor: Sirtsei Pharmaceuticals, Inc.
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-05
Locations: Alivation Research, Lincoln, Nebraska, 68526, United States

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 Measures: Brain Network Analytics Profile, 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., At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention
Secondary Outcome Measures: Brain Network Analytics Profile, 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 Day 1 post-dose will be compared to the BNA profile at Day 1 pre-dose to evaluate changes in the profile after a single dose of the assigned study intervention., At the Day 1 Visit, completed on study day 1 after the first dose of the assigned study intervention|Spatial Working Memory Test, At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)|Paired Associates Learning Test, At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)|Digit Symbol Substitution Test, At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)|Treatment Emergent Adverse Events, Through study completion, an average of 22 days