What side effects are associated with this type of intervention?

Common treatments for Major Depressive Disorder that involve the mTORC1 pathway, such as venlafaxine and fluvoxamine, have several known side effects. Venlafaxine can cause nausea, dry mouth, dizziness, insomnia, and increased blood pressure. Fluvoxamine may lead to side effects like nausea, sleep disturbances, sexual dysfunction, and increased sweating. Both medications can also have more severe side effects, including serotonin syndrome when combined with other serotonergic drugs. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several classes of medications for the treatment of Major Depressive Disorder (MDD), including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine, and atypical antidepressants like bupropion and mirtazapine. While specific FDA approvals for mTORC1 pathway modulators in MDD are not well-documented, the ongoing study of NV-5138 represents a novel approach targeting this pathway. Traditional treatments have focused on neurotransmitter modulation, but emerging therapies like NV-5138 aim to address underlying cellular mechanisms, potentially offering new hope for treatment-resistant depression.

What other types of research exist?

Promising novel alternatives to NV-5138 for MDD patients include: 1) Rapamycin, which has shown antidepressant effects by modulating the mTOR pathway. 2) S 47445, which has demonstrated efficacy in reversing behavioral and neuroplasticity changes in preclinical models. 3) Fluvoxamine, which has been found to involve the mTOR signaling in its antidepressant effects. 4) Venlafaxine, which activates the mTORC1 signaling cascade and has shown anti-stress effects in preclinical studies.

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NV-5138 for Treatment-Resistant Depression

Phase 2

Recruiting

Research Sponsored by Navitor Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of inadequate response to ≥2 but ≤4 prior ADT therapies (including the current ADT for the current MDE) ≥ 2 weeks at Screening and ≥ 8 weeks at Baseline.

18-70 years old?

Must not have

You have been diagnosed with Psychosis

You have been diagnosed with Bipolar Disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Summary

This trial is testing a new drug called NV-5138 to see if it can help adults whose depression hasn't improved with standard treatments. The drug works by changing brain chemicals to improve mood.

Who is the study for?

Adults aged 18-70 with Treatment Resistant Depression (TRD), who have tried and not responded to 2-4 antidepressant therapies, can join this study. They must be diagnosed with Major Depressive Disorder without psychotic features and show a certain level of depression severity on standard rating scales.

What is being tested?

The trial is testing NV-5138's effectiveness compared to a placebo in treating TRD. Participants will either receive NV-5138 or an inactive substance without knowing which one they're getting, to measure true effects of the drug.

What are the potential side effects?

Specific side effects for NV-5138 are not listed here, but common side effects for new depression treatments may include nausea, headache, dizziness, fatigue, changes in appetite or weight, sleep disturbances and mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I've tried 2-4 ADT therapies for my condition without success.

Select...

I have been on a stable dose of my depression medication for at least 2 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Evaluation of the efficacy of NV-5138 as measured by the Montgomery-Asberg Depression Rating scale

Secondary study objectives

Evaluation of the efficacy as measured by Clinical Global Impression-Severity (CGI-s) score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NV-5138 400 mg oral capsulesExperimental Treatment1 Intervention

Either 2 or 4 400 mg oral capsules administered once daily

Group II: matched placeboPlacebo Group1 Intervention

2 or 4 oral capsules administered once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NV-5138

2018

Completed Phase 1

~80

0 / 9Eligibility 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

Common treatments for Major Depressive Disorder (MDD) include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs). These treatments primarily work by increasing the levels of neurotransmitters such as serotonin, norepinephrine, and dopamine in the brain, which are often imbalanced in MDD patients. This neurotransmitter modulation helps alleviate depressive symptoms by improving mood, energy levels, and cognitive function. NV-5138, which targets the mTORC1 pathway, represents a novel approach by modulating cellular growth and synaptic plasticity, potentially offering faster and more robust antidepressant effects. Understanding these mechanisms is crucial for MDD patients as it helps tailor treatments to their specific neurochemical imbalances, improving the likelihood of remission and reducing the risk of treatment resistance.