Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression
Purpose
This study will evaluate the efficacy and safety of NV-5138 in adults with TRD
Condition
- Treatment Resistant Depression
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- randomized, double-blind, placebo-controlled
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- matched placebo
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NV-5138 400 mg oral capsules |
Either 2 or 4 400 mg oral capsules administered once daily |
|
|
Placebo Comparator matched placebo |
2 or 4 oral capsules administered once daily |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Navitor Pharmaceuticals, Inc.
Detailed Description
The is a multicenter, randomized, double-blind, flexible- dose, placebo-controlled, parallel design of adjunctive NV-5138 in adults with TRD.
