Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD (TERPSIS)

  • STATUS
    Recruiting
  • End date
    May 9, 2023
  • participants needed
    88
  • sponsor
    Neurocrine Biosciences
Updated on 9 July 2022

Summary

To evaluate the efficacy of NBI-1065846, used as adjunctive treatment to oral antidepressant medication(s), compared with placebo on improving symptoms of anhedonia in subjects with major depressive disorder (MDD).

Details
Condition Anhedonia, Major Depressive Disorder
Treatment Placebo, NBI-1065846
Clinical Study IdentifierNCT05165394
SponsorNeurocrine Biosciences
Last Modified on9 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must meet all of the following key inclusion criteria
Completed written informed consent
Aged 18 to 65 years, inclusive, at the time of informed consent
Diagnosis of MDD meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) and International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10)
Subject is currently on stable pharmacological treatment for depression, defined as ≤50% change in dose during the 6 weeks prior to randomization to ≥1 of the oral antidepressant medications listed in the MGH ATRQ
Snaith Hamilton Pleasure Scale (SHAPS) score is ≥30 at screening and Day 1

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the following key
criteria
Any psychiatric disorder disallowed per protocol and electroconvulsive therapy (ECT) within 6 months prior to screening. Comorbid anxiety disorders are not exclusionary
Have a significant risk of suicidal or violent behavior. Subjects with any suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) in the past 12 months before screening based on the C-SSRS or according to the investigator's clinical judgment should be excluded
A history of seizure disorder, stroke, Alzheimer disease, Parkinson disease, multiple sclerosis, head injury associated with loss of consciousness for more than 15 minutes, or other neurodegenerative disorder
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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