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Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05066672
Recruitment Status : Recruiting
First Posted : October 4, 2021
Last Update Posted : March 25, 2022
Supernus Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Navitor Pharmaceuticals, Inc.

Brief Summary:
This study will evaluate the efficacy and safety of NV-5138 in adults with TRD

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Drug: NV-5138 Drug: matched placebo Phase 2

Detailed Description:
The is a multicenter, randomized, double-blind, flexible- dose, placebo-controlled, parallel design of adjunctive NV-5138 in adults with TRD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, placebo-controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: matched placebo
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NV-5138 in Adults With Treatment Resistant Depression
Actual Study Start Date : February 28, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NV-5138 400 mg oral capsules
Either 2 or 4 400 mg oral capsules administered once daily
Drug: NV-5138
NV-5138 is a novel, orally bioavailable, selective, direct activator of mTORC1 cellular signaling
Other Name: SPN820

Placebo Comparator: matched placebo
2 or 4 oral capsules administered once daily
Drug: matched placebo
matched placebo oral capsules
Other Names:
  • placebo
  • PBO

Primary Outcome Measures :
  1. Evaluation of the efficacy of NV-5138 as measured by the Montgomery-Asberg Depression Rating scale [ Time Frame: 5 weeks ]
    Change from Baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. MADRS captures a clinician-rated score on a seven-point Likert scale for a score ranging from 0 to 60, with higher scores reflecting greater depression severity.

Secondary Outcome Measures :
  1. Evaluation of the efficacy as measured by Clinical Global Impression-Severity (CGI-s) score [ Time Frame: 5 weeks ]
    Change from baseline to end of treatment period on the Clinical Global Impression-Severity score for NV-5138 treated patients as compared to placebo. The CGI-S is a clinican-rated seven point scale from 0-7 where a higher rating represents higher severity of illness.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, aged 18 to 70 years at Screening.
  • Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for either recurrent or single episode MDD without psychotic features that is confirmed by the Mini International Neuropsychiatric Interview (MINI).
  • Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≥26 for the current MDE at all Screening visits and Baseline (Day 1).
  • CGI-S score of ≥4 (moderately ill or worse) at all Screening visits and Baseline.
  • 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.
  • Stable therapeutic dose of one of the following ADTs for the current MDE for ≥2 weeks prior to Screening and maintain the therapeutic dose throughout the study: citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine (IR or XR), desvenlafaxine, or vortioxetine.
  • Detectable blood level of the approved ADT at Visits 1 and 2 of the Screening Period.

Exclusion Criteria:

  • MADRS Total Score improvement of ≥25% from the highest to the lowest score at any visit during the Screening Period.
  • Clinically significant abnormal laboratory profiles, vital signs, or electrocardiograms (ECGs), per Investigator judgment.
  • Judged by the Investigator to be at significant risk for suicide, violence, or homicide; or answers 'Yes' to items 4 or 5 on the Suicidal Ideation section of the C-SSRS at Screening or at Baseline; or has attempted suicide within the 6 months prior to Screening.
  • History of psychotic disorder, including but not limited to schizophrenia, MDD with psychotic features, or bipolar I/II disorder with psychotic features.
  • History of PTSD, OCD, panic disorder, intellectual disability, autism, acute stress disorder, or Cluster A or B personality disorder (per DSM-5 criteria).
  • Any condition or procedure that may interfere with the absorption, metabolism, or elimination of the study medication (e.g., cholecystectomy or gastric bypass).
  • In the Investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason.
  • History of alcohol and/or substance use disorder within 6 months prior to Screening or is currently using or has positive results at Screening for drugs of abuse or has a positive alcohol result at any Screening or Baseline visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05066672

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Contact: Samuel Schaffer, MD 240-403-5758 samuel.schaffer@premier-research.com

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United States, Washington
Northwest Clinical Research Center, Inc. Recruiting
Bellevue, Washington, United States, 98007
Contact: Rachel Hall       rhall@nwcrc.net   
Principal Investigator: Arifulla Khan         
Sponsors and Collaborators
Navitor Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc.
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Study Director: Randy Owen, MD Medical Monitor
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Responsible Party: Navitor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05066672    
Other Study ID Numbers: NAV-17A-007
SPN820 ( Other Identifier: Supernus Pharmaceuticals, Inc. )
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders