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

NCT04479852 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2025-06-12

Study results available
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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.

Conditions

Interventions

DRUG

SP-624

Oral capsule

DRUG

Placebo

Oral capsule

Sponsors & Collaborators

  • Sirtsei Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Greg Rigdon, PhD · Sirtsei Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2022-06-27
Completion
2022-08-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04479852 on ClinicalTrials.gov