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NCT05113771 · ClinicalTrials.gov registry record · Phase 2
A Biomarker-Guided, Randomized, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With TRD
A Phase 2 study of Treatment-Resistant Depression, sponsored by Denovo Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 197
- Enrollment target
- 20
- Study locations
NCT05113771: Completed Phase 2 study of Treatment-Resistant Depression, sponsored by Denovo Biopharma.
NCT05113771 is a Phase 2 study of Treatment-Resistant Depression that has completed, run by Denovo Biopharma. The registered enrollment target is 197 participants, below the 370-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05113771, a Phase 2 study of Treatment-Resistant Depression, has completed, sponsored by Denovo Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 197 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary objective of this study was change of Montgomery Åsberg Depression Rating Scale (MADRS) total score (range = 0 60, with higher scores indicating more severe depression) in DGM4 positive patients who were treated with liafensine versus placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Liafensine
Study Locations (20)
California
- Collaborative Neuroschience Research, LLC - Garden Grove
- Behavioral Research Specialists, LLC - Glendale
- Sunwise Clinical Research, LLC. - Lafayette
- Excell Research - Oceanside
- Anderson Clinical Reseach - Redlands
- Schuster Medical Research Institute - Sherman Oaks
- Collaborative Neuroscience Research, LLC - Torrance
- Pacific Clinical Research Management Group - Upland
Florida
- Clinical Research of Brandon, LLC - Brandon
- Access Research Institute - Brooksville
- The Medicine Medical Research - Hollywood
- Nuovida Research Center - Miami
- SG Research, LLC - Miami
- Aqualane Clinical Research - Naples
- Clinical Neuroscience Solutions, Inc. - Orlando
Georgia
- CenExel Atlanta Center for Medical Research - Atlanta
- Psych Atlanta, PC - Marietta
Alabama
- University of Alabama at Birmingham - Huntsville
Arizona
- Alea Research - Phoenix
Illinois
- Revive Research Institute, Inc - Elgin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2022-06-29 |
| Est. Completion | 2024-03-05 |
| Phase | Phase 2 |
What the finished NCT05113771 record still lists
NCT05113771 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 370-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05113771 names 20 study sites across 6 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05113771 about?
NCT05113771 is a clinical study titled "A Biomarker-Guided, Randomized, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With TRD". 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...
What is the current status of trial NCT05113771?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 197 participants. The study started on 2022-06-29. Estimated completion is 2024-03-05.
What conditions does trial NCT05113771 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression.
What interventions are being tested in trial NCT05113771?
The interventions under investigation include: Placebo (DRUG), Liafensine (DRUG).
Who is sponsoring clinical trial NCT05113771?
This trial is sponsored by Denovo Biopharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05113771 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05113771's enrollment target sits among peer trials
197 11th of 54 higher than 44 of 54 other Treatment-Resistant Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Treatment-Resistant Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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