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Completed

NCT Number: NCT05165394

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

To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).

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Key information

Conditions

Anhedonia Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neurocrine Clinical Site, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Participants 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.
  • Primary diagnosis of MDD.
  • Participants must meet one of the following criteria:
  • must have been taking ≥1 antidepressant medication(s) for ≥8 weeks prior to screening.
  • must have received ≥1 antidepressant medication(s) for ≥8 weeks in the current or most recent episode of depression.
  • Snaith Hamilton Pleasure Scale (SHAPS) score is ≥30 at screening and Day 1.

Key Exclusion Criteria:

Participants 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.
  • 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.

Treatment and study plan

Placebo

Drug

Tablets for oral administration

NBI-1065846

Drug

Tablets for oral administration

Other names: TAK-041

Primary outcomes

  1. Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57

    Time frame: Baseline, Day 57

    The DARS is a dynamic scale that measured desire, motivation, effort and consummatory pleasure across hedonic domains. The DARS is a self-report questionnaire that measured anhedonia across 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. The DARs was rated on a five-point Likert scale from 0 (not at all) to 4 (very much), higher values indicating less anhedonia. All items were summed up to a total score in the range of 0 to 68.

Secondary outcomes

  1. Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression

    Time frame: Baseline, Day 57

    The MADRS is a validated rating scale designed to measure changes in the severity of depressive symptoms. The MADRS consists of 10 items scored on a 7-point scale (0 to 6). Higher MADRS scores indicate more severe depression. The MADRS total score was calculated as the sum of the 10 individual item scores which ranges from 0 to 60.

  2. CGI-S Scores

    Time frame: Baseline and Day 57

    The CGI-S scale, which is based on a 7-point scale (range: 1=normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = extremely ill), was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in Major Depressive Disorder (TERPSIS STUDY)

Acronym: TERPSIS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2021
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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