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NBI-1065846 for Anhedonia (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 weeks
Treatment ~ Varies
Follow Up ~baseline, day 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 57 for reporting.

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 • NCT05165394
7%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
NBI-1065846
Placebo

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
6,628 Total Patients Enrolled
1 Trials studying Anhedonia
23 Patients Enrolled for Anhedonia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,481 Total Patients Enrolled

Media Library

NBI-1065846 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05165394 — Phase 2
Anhedonia Research Study Groups: Antidepressant, Placebo
Anhedonia Clinical Trial 2023: NBI-1065846 Highlights & Side Effects. Trial Name: NCT05165394 — Phase 2
NBI-1065846 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05165394 — Phase 2
Anhedonia Patient Testimony for trial: Trial Name: NCT05165394 — Phase 2
~24 spots leftby Nov 2025