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A Biomarker-Guided, Randomized, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With TRD

NCT05113771 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2025-05-15

Study results available
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Summary

This study was conducted as a randomized, double-blind, placebo-controlled, multi-center Phase 2b study. Approximately 180 subjects with treatment resistant depression who meet all eligibility criteria will be enrolled. The primary endpoint is to demonstrate liafensine is superior to placebo in DGM4 positive patients with TRD.

Conditions

Interventions

DRUG

Liafensine

Liafensine

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Denovo Biopharma LLC

    lead INDUSTRY

Principal Investigators

  • Matthew A Spear, M.D. · Denovo Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-29
Primary Completion
2024-02-06
Completion
2024-03-05
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT05113771 on ClinicalTrials.gov