Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD
TERPSIS
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)
1 other identifier
interventional
93
2 countries
23
Brief Summary
To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2021
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2021
CompletedFirst Submitted
Initial submission to the registry
December 7, 2021
CompletedFirst Posted
Study publicly available on registry
December 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2023
CompletedResults Posted
Study results publicly available
July 31, 2024
CompletedJuly 31, 2024
July 1, 2024
1.6 years
December 7, 2021
July 3, 2024
July 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to 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.
Baseline, Day 57
Secondary Outcomes (2)
Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression
Baseline, Day 57
CGI-S Scores
Baseline and Day 57
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipant follows Placebo schedule (57 days)
Antidepressant
EXPERIMENTALParticipant follows NBI-1065846 schedule (57 days)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participants will be excluded from the study if they meet any of the following key criteria:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Neurocrine Clinical Site
Birmingham, Alabama, 35294, United States
Neurocrine Clinical Site
Garden Grove, California, 92845, United States
Neurocrine Clinical Site
Lemon Grove, California, 91945, United States
Neurocrine Clinical Site
Orange, California, 92868, United States
Neurocrine Clinical Site
Riverside, California, 92506, United States
Neurocrine Clinical Site
San Diego, California, 92103, United States
Neurocrine Clinical Site
San Francisco, California, 94107, United States
Neurocrine Clinical Site
Orlando, Florida, 32803, United States
Neurocrine Clinical Site
Pensacola, Florida, 32502, United States
Neurocrine Clinical Site
Winter Park, Florida, 32792, United States
Neurocrine Clinical Site
Atlanta, Georgia, 30338, United States
Neurocrine Clinical Site
Chicago, Illinois, 60641, United States
Neurocrine Clinical Site
Skokie, Illinois, 60076, United States
Neurocrine Clinical Site
Saint Charles, Missouri, 63304, United States
Neurocrine Clinical Site
Raleigh, North Carolina, 27609, United States
Neurocrine Clinical Site
Columbus, Ohio, 43210, United States
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73112, United States
Neurocrine Clinical Site
Dallas, Texas, 75235, United States
Neurocrine Clinical Site
Friendswood, Texas, 77546, United States
Neurocrine Clinical Site
Houston, Texas, 77030, United States
Neurocrine Clinical Site
Murray, Utah, 84107, United States
Neurocrine Clinical Site
Everett, Washington, 98201, United States
Neurocrine Clinical Site
San Juan, 00926, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neurocrine Medical Information Call Center
- Organization
- Neurocrine Biosciences
Study Officials
- STUDY DIRECTOR
Clinical Development Lead
Neurocrine Biosciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2021
First Posted
December 21, 2021
Study Start
November 30, 2021
Primary Completion
July 7, 2023
Study Completion
September 13, 2023
Last Updated
July 31, 2024
Results First Posted
July 31, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share