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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
Awards & highlights

TERPSIS Trial Summary

This trial is testing a new drug to see if it helps people with depression who are also taking an antidepressant.

Eligible Conditions
  • Anhedonia
  • Depression

TERPSIS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in anhedonia severity, as measured by change in Dimensional Anhedonia Rating Scale (DARS) score from baseline to Day 57
Secondary outcome measures
Change in Clinical Global Impression - Severity (CGI-S) score from baseline to Day 57
Change in total Montgomery Åsberg Depression Rating Scale (MADRS) score from baseline to Day 57 in participants with moderate or higher severity depression

TERPSIS 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
6,658 Total Patients Enrolled
1 Trials studying Anhedonia
23 Patients Enrolled for Anhedonia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,484 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it permissible for me to join this trial?

"This medical trial is recruiting 88 individuals, aged 18-65 years old, who suffer from anhedonia and MDD. Specific requirements are: written informed consent has to be provided; participants should have been on a stable antidepressant medication for the past 6 weeks prior to randomization as listed in MGH ATRQ; SHAPS score of 30 or higher at screening & Day 1."

Answered by AI

How many individuals are expected to sign up for this experiment?

"Affirmative. According to the clinicaltrials.gov registry, recruitment for this trial is still taking place and has been since November 30th 2021. The most recent update was on November 23rd 2022 and 88 participants are needed from 16 different sites in total."

Answered by AI

Is there evidence to suggest that NBI-1065846 is a safe remedy for humans?

"Although there is limited scientific data to back up the efficacy of NBI-1065846, prior studies suggest it has a fairly high safety rating (2 out of 3)."

Answered by AI

Are any participants being enrolled at this time for the trial?

"According to the info on clinicaltrials.gov, this trial is still welcoming applicants. The post was initially published on November 30th 2021 and has recently been updated as of November 23rd 2022."

Answered by AI

Are individuals aged 45 or above being enlisted as participants in this experiment?

"Applicants aged 18 to 65 are eligible for this specific clinical trial. For those younger or older than the age range, there are 194 trials readily available for minors and 970 suitable studies accessible to seniors."

Answered by AI

How many physical locations are overseeing this trial?

"At present, 16 healthcare facilities are recruiting for this clinical trial - ranging from San Francisco and San Diego to Friendswood. Selecting a clinic nearby can facilitate the participation process by reducing travel requirements."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Neurocrine Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I take Lexapro for depression but still occasionally experience waves of depression. I'm curious if this will help.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long will the trial last? Is it paid?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD
2021. "Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05165394.
~28 spots leftby Apr 2025
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