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A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder

Phase 2
Waitlist Available
Research Sponsored by Sirtsei Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 weeks

Summary

This trial is testing a new treatment called SP-624 to see if it is safe and effective for adults with Major Depressive Disorder. It aims to help those who haven't found relief with usual treatments by adjusting brain chemicals related to mood.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) total score
Secondary study objectives
Change from Baseline to Week 2 and Week 4 in the 17-item Hamilton Depression Rating Scale (HAM D-17) total score
Change from Baseline to Week 2 and Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Change from Baseline to Week 2 and Week 4 in the Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SP-624Experimental Treatment1 Intervention
Daily oral capsule, 20 mg/day
Group II: PlaceboPlacebo Group1 Intervention
Daily oral capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SP-624
2020
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Sirtsei Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
519 Total Patients Enrolled
1 Trials studying Depression
36 Patients Enrolled for Depression
Greg Rigdon, PhDStudy DirectorSirtsei Pharmaceuticals, Inc.
1 Previous Clinical Trials
456 Total Patients Enrolled
~58 spots leftby Dec 2025
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