Bellevue, Washington 98007

  • Treatment Resistant Depression


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.


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.



Primary Contact:

Study Director
Randy Owen, MD
Medical Monitor

Samuel Schaffer, MD
Phone: 240-403-5758

Backup Contact:


Location Contact:

Bellevue, Washington 98007
United States

Rachel Hall

Site Status: Recruiting

Data Source:

Date Processed: June 28, 2022

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.