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

Treatment Resistant Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05066672
• Other study ID #: NAV-17A-007
• Secondary ID: SPN820
• Status: Recruiting
• Phase: Phase 2
• Start date: February 28, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Navitor Pharmaceuticals, Inc.
• Contact: Samuel Schaffer, MD
• Phone: 240-403-5758
• Email: samuel.schaffer[@]premier-research.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Drug:
• NV-5138
NV-5138 is a novel, orally bioavailable, selective, direct activator of mTORC1 cellular signaling
• matched placebo
matched placebo oral capsules

Locations

Country	Name	City	State
United States	Northwest Clinical Research Center, Inc.	Bellevue	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Navitor Pharmaceuticals, Inc.	Supernus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the efficacy of NV-5138 as measured by the Montgomery-Asberg Depression Rating scale	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.	5 weeks
Secondary	Evaluation of the efficacy as measured by Clinical Global Impression-Severity (CGI-s) score	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.	5 weeks