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RecruitingPhase 3NCT06741228

A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)

Trial Parameters

ConditionGeneralized Anxiety Disorder
SponsorDefinium Therapeutics US, Inc.
Study TypeINTERVENTIONAL
PhasePhase 3
Enrollment200
SexALL
Min Age18 Years
Max Age74 Years
Start Date2024-12-11
Completion2026-05
Interventions
PlaceboMM120 (LSD D-Tartrate)

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Brief Summary

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Voyage

Eligibility Criteria

Inclusion Criteria: 1. Diagnosis of GAD per DSM-5 2. Male or female aged 18 to 74 3. HAM-A Total Score ≥20 Exclusion Criteria: 1. Certain psychiatric disorders (other than generalized anxiety disorder) 2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder 3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine) 4. Any clinically significant unstable illness

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