Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570369
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-17
Brief Title:
A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None