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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings in this experimental research currently?

"Clinicaltrials.gov confirms that this research is still actively seeking suitable patients, with the original posting date being June 29th 2022 and subsequent updates as late as October 4th 2022."

Answered by AI

Can I participate in this experiment under the current criteria?

"Eligible participants for this clinical trial must have depression and be aged between 18-70 years old. Approximately 180 people will receive an invitation to join the study."

Answered by AI

Is this a pioneering attempt to address the issue?

"Since 2022, Liafensine has been under clinical investigation; an original 180 patient trial sponsored by Denovo Biopharma LLC was completed in the same year. After successful Phase 2 drug approval, a single clinical study for Liafensine is currently underway, still hosted by its creator Denovo Biopharma LLC."

Answered by AI

How many individuals are currently participating in this experiment?

"To move forward with this clinical trial, 180 individuals that meet the eligibility requirements must be conscripted. Interested patients may join from two separate locations: University of Texas Medical School at Houston in Houston, TX and Collaborative Neuroschience Research LLC in Garden Grove, CA."

Answered by AI

Has Liafensine been investigated in any further research studies?

"Currently, one clinical trial is utilizing Liafensine. This study has not yet advanced to Phase 3 trials and enrolment locations span 24 cities with most situated in Baltimore, Maryland."

Answered by AI

What is the scope of this experiment in terms of medical establishments?

"This clinical trial is recruiting participants at the University of Texas Medical School in Houston, Collaborative Neuroscience Research based in Garden Grove, and Bio Behavior Health located in Toms River. Additionally, there are 24 other sites offering enrollment for this study."

Answered by AI

Are there any adverse effects associated with Liafensine usage?

"The safety of Liafensine has been assigned a score of 2 since there is some evidence to support its security but no data yet that demonstrates its efficacy."

Answered by AI

Is this trial open to individuals of advanced age?

"The parameters for entry into this medical trial necessitate that the patient is between 18 and 70 years old. For those below age of consent, there are 191 trials available while 969 clinical studies exist for patients over 65."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Florida
California
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Neurobehavioral Medicine Group
Schuster Medical Research Institute
Sunwise Clinical Research, LLC.
Other
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

To find a way out. Zoloft lexipro paxil. Nothing works for me. I’m always depressed.
PatientReceived 1 prior treatment
I have been depressed.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Why is it so far? What is this trial? Where is it located? What is the outcome?
PatientReceived 2+ prior treatments
How soon will start?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Alea Research: < 24 hours
  2. Pharmasite Research, Inc.: < 48 hours
  3. Zucker Hillside Hospital: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Biomarker-Guided, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With Treatment Resistant Depression
2022. "A Biomarker-Guided, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With Treatment Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05113771.
~8 spots leftby Jun 2024
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