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

NCT ID: NCT06570369

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-22

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder Depression Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SP-624

SP-624 oral capsule, once daily for 2 weeks

Group Type EXPERIMENTAL

SP-624

Intervention Type DRUG

Oral dose, once daily for 2 weeks

Placebo

Placebo oral capsule, once daily for 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral dose, once daily for 2 weeks

Interventions

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SP-624

Oral dose, once daily for 2 weeks

Intervention Type DRUG

Placebo

Oral dose, once daily for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sirtsei Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CenExel CNS

Garden Grove, California, United States

Site Status RECRUITING

Alivation Research

Lincoln, Nebraska, United States

Site Status COMPLETED

Countries

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United States

Facility Contacts

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CNS Outreach Department

Role: primary

Other Identifiers

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SP-624-103

Identifier Type: -

Identifier Source: org_study_id