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

NCT06570369 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SP-624-103
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder; Depression; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Brain Network Analytics Profile

  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

Study Arms (2)

SP-624

EXPERIMENTAL

SP-624 oral capsule, once daily for 2 weeks

Drug: SP-624

Placebo

PLACEBO COMPARATOR

Placebo oral capsule, once daily for 2 weeks

Drug: Placebo

Interventions

SP-624 DRUG

Oral dose, once daily for 2 weeks

SP-624

Placebo DRUG

Oral dose, once daily for 2 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Female who is pregnant or breastfeeding.
• Clinically significant health condition or clinically significant abnormal results on screening health tests

Sponsors & Collaborators

• Sirtsei Pharmaceuticals, Inc.: lead

Study Sites (2)

CenExel CNS

Garden Grove, California, 92845, United States

RECRUITING

Alivation Research

Lincoln, Nebraska, 68526, United States

COMPLETED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 26, 2024
• Study Start: August 22, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)