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Serotonin–norepinephrine–dopamine reuptake inhibitor

Liafensine for Treatment Resistant Depression (ENLIGHTEN Trial)

Verified Trial
Phase 2
Waitlist Available
Research Sponsored by Denovo Biopharma LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you experiencing depression now?
In the past 5 years, have you taken two or more different antidepressants that felt ineffective for you?
Timeline
Screening 21 days
Treatment 4 weeks
Follow Up 28 days
Awards & highlights

ENLIGHTEN Trial Summary

This trial will study a new treatment for depression in people who haven't responded well to other treatments. Around 180 people will be randomly assigned to receive either the new treatment or a placebo. Neither the participants nor the researchers will know who is receiving which until the end of the trial.

Who is the study for?
This trial is for individuals with treatment-resistant Major Depressive Disorder, specifically those with the DGM4 genotype who have tried at least two antidepressants without success in the past 5 years. Men must comply with pregnancy prevention measures. People currently responding well to treatments, with substance abuse issues, significant health abnormalities, or recent cancer history (except certain skin cancers) cannot participate.Check my eligibility
What is being tested?
The study tests Liafensine's effectiveness and safety against a placebo in patients with treatment-resistant depression. It's a Phase 2b trial involving about 180 participants who are randomly assigned to receive either Liafensine or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects of Liafensine aren't listed here, common side effects of antidepressants can include nausea, increased appetite and weight gain, loss of sexual desire or other sexual problems such as erectile dysfunction and decreased orgasm, fatigue and drowsiness, insomnia, dry mouth, blurred vision and constipation.

ENLIGHTEN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are currently experiencing depression.
Select...
You have taken two or more different antidepressants within the past 5 years that felt ineffective.

ENLIGHTEN Trial Timeline

Screening ~ 21 days
Treatment ~ 4 weeks
Follow Up ~28 days
This trial's timeline: 21 days for screening, 4 weeks for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in MADRS Total Score

ENLIGHTEN Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Liafensine 2mgExperimental Treatment1 Intervention
Group II: Liafensine 1mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Denovo Biopharma LLCLead Sponsor

Media Library

Liafensine (Serotonin–norepinephrine–dopamine reuptake inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05113771 — Phase 2
Major Depressive Disorder Research Study Groups: Liafensine 1mg, Liafensine 2mg, Placebo
Major Depressive Disorder Clinical Trial 2023: Liafensine Highlights & Side Effects. Trial Name: NCT05113771 — Phase 2
Liafensine (Serotonin–norepinephrine–dopamine reuptake inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05113771 — Phase 2
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05113771 — Phase 2
~0 spots leftby Jun 2024
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