NBI-1065846 for Anhedonia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Anhedonia+1 MoreNBI-1065846 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline and Day 57

Baseline and Day 57
Change in Clinical Global Impression - Improvement (CGI-I) score from baseline to Day 57.
Change in Clinical Global Impression - Severity (CGI-S) score from baseline to Day 57.
Change in anhedonia severity, as measured by change in Dimensional Anhedonia Rating Scale (DARS), from baseline to Day 57
Change in total Montgomery Åsberg Depression Rating Scale (MADRS) score from baseline to Day 57 in subjects with moderate or higher severity depression.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Antidepressant
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

88 Total Participants · 2 Treatment Groups

Primary Treatment: NBI-1065846 · Has Placebo Group · Phase 2

Antidepressant
Drug
Experimental Group · 1 Intervention: NBI-1065846 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and day 57

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
70 Previous Clinical Trials
6,706 Total Patients Enrolled
1 Trials studying Anhedonia
23 Patients Enrolled for Anhedonia
Clinical Development LeadStudy DirectorNeurocrine Biosciences
21 Previous Clinical Trials
2,540 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently on stable pharmacological treatment for depression, defined as ≤50% change in dose during the 6 weeks prior to randomization to ≥1 of the oral antidepressant medications listed in the MGH ATRQ.
You have a SHAPS score of ≥30 at screening and Day 1.