MedTrace Logo

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

NCT06254612 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SP-624

Once daily oral administration of two capsules totaling 20 mg/day

DRUG

Placebo

Once daily oral administration of two matching placebo capsules

Sponsors & Collaborators

  • Rho, Inc.

    collaborator INDUSTRY

  • 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
2024-03-25
Primary Completion
2026-07-15
Completion
2026-07-15
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 NCT06254612 on ClinicalTrials.gov