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

Launched by NAVITOR PHARMACEUTICALS, INC. · Sep 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NV-5138 for adults who are struggling with treatment-resistant depression (TRD). TRD is when people have not found relief from their depression symptoms after trying multiple medications. In this study, researchers want to see if NV-5138 can help improve symptoms and if it is safe for patients to use. The trial is open to men and women aged 18 to 70 who have been diagnosed with major depressive disorder and have not responded well to at least two different antidepressant treatments in the past.

Participants in this trial can expect to undergo several assessments to confirm their eligibility, including questionnaires to measure their depression severity. They will need to be on a stable dose of a current antidepressant for at least two weeks before joining the study. Throughout the trial, participants will receive close monitoring and support from the research team. It's important to note that certain individuals, such as those with a history of severe mental health issues or substance use, may not be eligible to participate for their safety. This study aims to find new ways to help those who have not benefited from traditional treatments for depression.

Gender

ALL

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.