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Completed

NCT Number: NCT06570369

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Healthy Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel CNS, Garden Grove, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SP-624

Drug

Oral dose, once daily for 2 weeks

Placebo

Drug

Oral dose, once daily for 2 weeks

Primary outcomes

  1. Brain Network Analytics Profile

    Time frame: 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 outcomes

  1. Brain Network Analytics Profile

    Time frame: 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.

  2. Spatial Working Memory Test

    Time frame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)

  3. Paired Associates Learning Test

    Time frame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)

  4. Digit Symbol Substitution Test

    Time frame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)

  5. Treatment Emergent Adverse Events

    Time frame: Through study completion, an average of 22 days

Sponsors and collaborators

Lead sponsor

Sirtsei Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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