CompletedPhase 2

Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD

United States93 participantsStarted 2021-11-30

Plain-language summary

To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).

Who can participate

Age range18 Years – 65 Years

SexALL

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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:
✓. Snaith Hamilton Pleasure Scale (SHAPS) score is ≥30 at screening and Day 1.

Exclusion 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.

What they're measuring

Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57

Timeframe: Baseline, Day 57

Trial details

NCT IDNCT05165394

SponsorNeurocrine Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-07

Results submitted2024-07-03

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