Bellevue, Washington 98007

  • Treatment Resistant Depression

Purpose:

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


Study summary:

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


Criteria:

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.


NCT ID:

NCT05066672


Primary Contact:

Study Director
Randy Owen, MD
Medical Monitor

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


Backup Contact:

N/A


Location Contact:

Bellevue, Washington 98007
United States

Rachel Hall
Email: rhall@nwcrc.net

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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