drugset / Trial / NCT04479852

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

NCT04479852 ↗

Phase 2 Completed 319 enrolled Sirtsei Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 2 clinical study evaluating the safety and effectiveness of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.

Timeline

Start
2020-09-30
Primary completion
2022-06-27
Completion
2022-08-09

Outcome

Missed primary endpoint

registry analysis (superiority test); SP-624 vs Placebo; p = 0.133; Mean Difference (Final Values) -1.8 (95% CI -4.1 to 0.5); Mixed Models Analysis NCT04479852 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject SP-624 Unknown 20 mg Oral