Clinical trial NCT05066672: Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Treatment Resistant Depression
Lead sponsor: Navitor Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Supernus Pharmaceuticals, Inc.
First posted: 2021-10-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Evaluation of the efficacy of NV-5138 as measured by the Montgomery-Asberg Depression Rating scale
timeFrame: 5 weeks
Secondary outcomes:
measure: Evaluation of the efficacy as measured by Clinical Global Impression-Severity (CGI-s) score
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Northwest Clinical Research Center, Inc.
state: Washington
Study officials:
affiliation: Medical Monitor
name: Randy Owen, MD
role: STUDY_DIRECTOR
References: