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NCT06254612

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

A Multi-center, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
Sirtsei Pharmaceuticals, Inc.·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Major Depressive Disorder
Drug/Device/Intervention
SP-624
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sirtsei Pharmaceuticals, Inc.
Location
Phoenix,Bellflower,Lafayette,Lemon Grove,Oceanside,Torrance,Lauderhill,Miami Lakes,Orlando,Las Vegas,Berlin,Cherry Hill,Portland,Everett, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Mar 19, 2024
End date
Jul 11, 2025
Enrollment
456 participants
Primary outcome

Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

Summary

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

ICD-10 classifications
Recurrent depressive disorderRecurrent depressive disorder, unspecifiedDepressive conduct disorderOther recurrent depressive disordersRecurrent depressive disorder, current episode moderate
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06254612
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06254612 through Pure Global AI's free database. This Phase 2 trial is sponsored by Sirtsei Pharmaceuticals, Inc. and is currently Recruiting. The study focuses on Major Depressive Disorder. Target enrollment is 456 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.