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

Sirtsei Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Major Depressive Disorder

Depression

Treatments

Drug: Placebo

Drug: SP-624

Study type

Interventional

Funder types

Industry

Identifiers

NCT06570369

SP-624-103

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.