Clinical trial NCT06570369: A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Major Depressive Disorder
Depression
Healthy
Lead sponsor: Sirtsei Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Brain Network Analytics Profile
timeFrame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention
Secondary outcomes:
measure: Brain Network Analytics Profile
timeFrame: At the Day 1 Visit, completed on study day 1 after the first dose of the assigned study intervention
measure: Spatial Working Memory Test
timeFrame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)
measure: Paired Associates Learning Test
timeFrame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)
measure: Digit Symbol Substitution Test
timeFrame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)
measure: Treatment Emergent Adverse Events
timeFrame: Through study completion, an average of 22 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Alivation Research
state: Nebraska
Study officials:
References: