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

Phase 2

Completed

• Conditions: Treatment Resistant Depression
• Interventions: Drug: matched placebo; Drug: NV-5138

• Registration Number: NCT05066672
• Lead Sponsor: Navitor Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-04
• Study Start: 2022-02-28
• Primary Completion: 2025-02-15
• Study Completion: 2025-02-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
matched placebo	matched placebo	2 or 4 oral capsules administered once daily
NV-5138 400 mg oral capsules	NV-5138	Either 2 or 4 400 mg oral capsules administered once daily

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Northwest Clinical Research Center, Inc.; 🇺🇸 Bellevue, Washington, United States