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

Navitor Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Treatment Resistant Depression

Treatments: Drug: matched placebo; Drug: NV-5138

Study type: Interventional

Funder types: Industry

Identifiers

NCT05066672

NAV-17A-007

SPN820 (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

NV-5138 400 mg oral capsules

Experimental group

Description:

Either 2 or 4 400 mg oral capsules administered once daily

Treatment:

Drug: NV-5138

matched placebo

Placebo Comparator group

Description:

2 or 4 oral capsules administered once daily

Treatment:

Drug: matched placebo