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Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD (TERPSIS Trial)
Phase 2
Waitlist Available
Research Sponsored by Neurocrine Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 57
Summary
This trial is testing a new medication called NBI-1065846 to see if it can help people with major depressive disorder who struggle with feeling pleasure. The goal is to improve their ability to feel pleasure by affecting brain chemicals or pathways.
Eligible Conditions
- Anhedonia
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 57
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 57
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57
Secondary study objectives
CGI-S Scores
Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression
Side effects data
From 2023 Phase 2 trial • 93 Patients • NCT051653947%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
NBI-1065846
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AntidepressantExperimental Treatment1 Intervention
Participant follows NBI-1065846 schedule (57 days)
Group II: PlaceboPlacebo Group1 Intervention
Participant follows Placebo schedule (57 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NBI-1065846
2021
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,236 Total Patients Enrolled
1 Trials studying Anhedonia
23 Patients Enrolled for Anhedonia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,089 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high chance of acting violently or harming yourself.You have been diagnosed with major depressive disorder (MDD).You have a history of seizures, stroke, Alzheimer's disease, Parkinson's disease, multiple sclerosis, a severe head injury where you lost consciousness for more than 15 minutes, or any other brain disorder that causes progressive loss of function.You need to meet at least one of the following conditions:You have to have been taking at least one antidepressant for at least 8 weeks before being screened for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Antidepressant
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anhedonia Patient Testimony for trial: Trial Name: NCT05165394 — Phase 2