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SP-624 for Major Depression

Phase 1
Recruiting
Research Sponsored by Sirtsei Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For participants with depression: must meet study criteria for moderate to severe major depressive disorder
Be between 18 and 65 years old
Must not have
Female who is pregnant or breastfeeding
Clinically significant health condition or clinically significant abnormal results on screening health tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the day 1 visit, completed on study day 1 after the first dose of the assigned study intervention
Awards & highlights

Summary

This trial aims to see if a new drug, SP-624, affects brain activity and memory in healthy adults and adults with major depression. The study will also assess the safety and tolerability of SP

Who is the study for?
This trial is for healthy adults and those with major depression. Participants will take capsules daily for 2 weeks, visit the clinic on specific days, and have phone check-ups. Key exclusions aren't listed but typically include certain medical conditions or treatments that could interfere with the study.
What is being tested?
The trial tests SP-624's impact on brain activity, memory, and learning in healthy adults and those with major depression. It involves comparing SP-624 to a placebo to see if there are any differences in test outcomes after two weeks of treatment.
What are the potential side effects?
While specific side effects of SP-624 are not detailed here, common ones may include nausea, headaches, dizziness or sleep disturbances. Safety and tolerability will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with moderate to severe depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have a serious health condition or abnormal test results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the day 1 visit, completed on study day 1 after the first dose of the assigned study intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the day 1 visit, completed on study day 1 after the first dose of the assigned study intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Brain Network Analytics Profile

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SP-624Experimental Treatment1 Intervention
SP-624 oral capsule, once daily for 2 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo oral capsule, once daily for 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SP-624
2020
Completed Phase 1
~30

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sirtsei Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
783 Total Patients Enrolled
1 Trials studying Depression
300 Patients Enrolled for Depression
~24 spots leftby May 2025
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