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NCT07901179

A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Incidence of treatment-emergent adverse events
Timeframe: Up to 8 weeks

Secondary (2)

Change from Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Change in Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S)

Arms and interventions

ALKS 7290 and Antidepressant TherapyExperimental
Placebo and Antidepressant TherapyPlacebo comparator

Drugs: ALKS 7290 Dose, Placebo

Sites

1 site in 1 country

  • Alkermes Investigator SiteJacksonville, Florida, United States