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

Last updated: October 27, 2025
Sponsor: Sirtsei Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Depression (Major/severe)

Depression

Mood Disorders

Treatment

SP-624

Placebo

Clinical Study ID

NCT06570369
SP-624-103
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 severemajor depressive disorder

Exclusion

Key Exclusion Criteria:

  • Female who is pregnant or breastfeeding.

  • Clinically significant health condition or clinically significant abnormal resultson screening health tests

  • For participants with depression: presence of exclusionary study criteria forco-morbid psychiatric conditions or medication history.

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: SP-624
Phase: 1
Study Start date:
August 22, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • CenExel CNS

    Garden Grove, California 92845
    United States

    Site Not Available

  • CenExel CNS

    Garden Grove 5351515, California 5332921 92845
    United States

    Active - Recruiting

  • Alivation Research

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Alivation Research

    Lincoln 5072006, Nebraska 5073708 68526
    United States

    Completed

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