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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Healthy; Major Depressive Disorder
• Intervention / Treatment: Drug: SP-624; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92845
      • CenExel CNS
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SP-624; SP-624 oral capsule, once daily for 2 weeks	Drug: SP-624; Oral dose, once daily for 2 weeks
Placebo Comparator: Placebo; Placebo oral capsule, once daily for 2 weeks	Drug: Placebo; Oral dose, once daily for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sirtsei Pharmaceuticals, Inc.
• Investigators: Study Director: Joel Raskin, MD, Sirtsei Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Actual): May 11, 2026
• Study Completion (Actual): May 18, 2026

Study Registration Dates

• First Submitted: August 17, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Behavior; Depression; Depressive Disorder, Major
• Other Study ID Numbers: SP-624-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No