RecruitingPhase 1NCT06570369

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


Sponsor

Sirtsei Pharmaceuticals, Inc.

Enrollment

36 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests an investigational drug called SP-624 to see how it affects brain activity patterns (brain network analytics) measured by EEG (a painless brain scan) and other assessments. The study includes both healthy adults and adults with moderate to severe major depression to understand how SP-624 affects brain function. **You may be eligible if:** - You are a generally healthy adult - Your body mass index (BMI) is between 18 and 40 - You are willing to follow the study requirements - If you have depression: you have moderate to severe major depressive disorder meeting specific study criteria **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have a significant health condition or abnormal results on screening tests - If you have depression: you have certain other psychiatric conditions or a medication history that makes you ineligible Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSP-624

Oral dose, once daily for 2 weeks

DRUGPlacebo

Oral dose, once daily for 2 weeks


Locations(2)

CenExel CNS

Garden Grove, California, United States

Alivation Research

Lincoln, Nebraska, United States

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NCT06570369


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