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

Phase 1

Recruiting

• Conditions: Major Depressive Disorder; Depression; Healthy
• Interventions: Drug: Placebo; Drug: SP-624

• Registration Number: NCT06570369
• Lead Sponsor: Sirtsei Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08
• Study First Submitted: 2024-08-17
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo oral capsule, once daily for 2 weeks
SP-624	SP-624	SP-624 oral capsule, once daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
Brain Network Analytics Profile	At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention	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.

Secondary Outcome Measures

Name	Time	Method
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)
Brain Network Analytics Profile	At the Day 1 Visit, completed on study day 1 after the first dose of the assigned study intervention	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.
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

Trial Locations

Locations (1)

Alivation Research; 🇺🇸 Lincoln, Nebraska, United States