What side effects are associated with this type of intervention?

Common treatments for Major Depressive Disorder (MDD) include SSRIs, SNRIs, atypical antidepressants, and NMDA receptor antagonists like ketamine. SSRIs (e.g., fluoxetine, sertraline) often cause side effects such as nausea, insomnia, sexual dysfunction, and weight gain. SNRIs (e.g., venlafaxine, duloxetine) can lead to similar side effects, including increased blood pressure. Atypical antidepressants (e.g., bupropion, mirtazapine) may cause dry mouth, dizziness, and weight changes. Ketamine, used for treatment-resistant depression, can cause dissociation, increased blood pressure, and potential for abuse. Patients should discuss these side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Major Depressive Disorder that modulate neurotransmitter systems. Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, are commonly used. Additionally, atypical antidepressants like mirtazapine and bupropion, which affect norepinephrine and dopamine, have also been approved. Monoamine oxidase inhibitors (MAOIs) like phenelzine are another class, though less commonly used due to dietary restrictions and side effects. These treatments aim to balance neurotransmitter levels to alleviate depressive symptoms.

What other types of research exist?

Promising novel alternatives for Major Depressive Disorder in 2024 include: 1) Ketamine and esketamine, which are NMDA receptor antagonists showing rapid antidepressant effects. 2) Augmentation therapies such as aripiprazole and quetiapine, which have been effective in treatment-resistant cases. 3) Electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS), which are non-pharmacological options with strong evidence for efficacy. 4) Liafensine, a novel antidepressant currently under investigation in Phase 2b trials for treatment-resistant depression.

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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 below

Select...

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

This trial's timeline: 21 days for screening, 4 weeks for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in MADRS Total Score

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

0 / 3Eligibility criteria met

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.