Phase 2
N=93
Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD
Anhedonia · Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05165394 ↗Enrolled (actual)
93
Serious AEs
1.1%
Results posted
Jul 2024
Primary outcome: Primary: Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57 — 17.4; 13.5 units on a scale — p=0.8663
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); NBI-1065846 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neurocrine Biosciences
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57 |
17.4; 13.5 | 0.8663 |
| SECONDARY Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression |
-13.9; -15.1 | 0.7008 |
| SECONDARY CGI-S Scores |
0; 0; 0; 0; 1; 1 | 0.9051 |
Summary
To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).
Eligibility Criteria
Key Inclusion Criteria
Participants must meet all of the following key inclusion criteria:
- 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.
Key Exclusion Criteria
Participants will be excluded from the study if they meet any of the following key criteria:
- Any psychiatric disorder disallowed per protocol and electroconvulsive therapy (ECT) within 6 months prior to screening. Comorbid anxiety disorders are not exclusionary.
- 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.
Data sourced from ClinicalTrials.gov (NCT05165394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.