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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 belowSelect...
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
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
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.
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Who is running the clinical trial?
Navitor Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
136 Total Patients Enrolled
Supernus Pharmaceuticals, Inc.Industry Sponsor
47 Previous Clinical Trials
13,384 Total Patients Enrolled
Randy Owen, MDStudy DirectorMedical Monitor