RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2024-08-22
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06570369

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * In generally good health
  2. * Body mass index (BMI) between 18.0 and 40.0 kg/m2
  3. * Willing to comply with the requirements of the study
  4. * For participants with depression: must meet study criteria for moderate to severe major depressive disorder
  1. * Female who is pregnant or breastfeeding.
  2. * Clinically significant health condition or clinically significant abnormal results on screening health tests
  3. * For participants with depression: presence of exclusionary study criteria for co-morbid psychiatric conditions or medication history.

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Sirtsei Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-22
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-08-22
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder
  • Depression
  • Healthy