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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
Summary
This trial is testing a new treatment for people with depression who haven't responded to other treatments. The study will compare the new treatment to see if it helps improve their symptoms. Psilocybin-assisted therapy may be a new treatment for major depressive disorder (MDD), with encouraging data from pilot trials.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are currently experiencing depression.
Select...
You have taken two or more different antidepressants within the past 5 years that felt ineffective.
Timeline
Screening ~ 21 days9 visits
Treatment ~ 4 weeks5 visits
Follow Up ~ 28 days2 visits
Screening ~ 21 days
Treatment ~ 4 weeks
Follow Up ~28 days
Treatment Details
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Major Depressive Disorder (MDD) primarily involve the modulation of neurotransmitter systems, including serotonin, norepinephrine, and dopamine. Selective serotonin reuptake inhibitors (SSRIs) increase serotonin levels by inhibiting its reuptake into the presynaptic cell, enhancing mood and emotional stability.
Serotonin-norepinephrine reuptake inhibitors (SNRIs) similarly inhibit the reuptake of both serotonin and norepinephrine, addressing a broader range of depressive symptoms. Dopamine reuptake inhibitors increase dopamine levels, which can improve motivation and pleasure.
These mechanisms are crucial for MDD patients as they directly target the chemical imbalances in the brain that contribute to depressive symptoms, offering relief and improving overall mental health.
Find a Location
Who is running the clinical trial?
Denovo Biopharma LLCLead Sponsor
17 Previous Clinical Trials
2,900 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have previously taken part in a study involving the drug liafensine.You have a medical condition that could interfere with how your body processes liafensine.You have had cancer within the past two years, except for non-spreading skin cancer.You have taken two or more different antidepressants within the past 5 years that felt ineffective.You are currently experiencing depression.Male patients must not father a child during the study.You have had a problem with alcohol or drugs (except for nicotine or caffeine) within the last 6 months according to the DSM-5 criteria.Your vital signs (such as blood pressure, heart rate, and temperature) are outside of the normal range during the screening process, indicating a potential health issue.
Research Study Groups:
This trial has the following groups:- Group 1: Liafensine 1mg
- Group 2: Liafensine 2mg
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 21 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 4 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 28 Months after you stop receiving the treatment.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05113771 — Phase 2