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Clinical Trials in the USA / NCT06741228
Active, not recruiting Phase 3

A Phase 3 Trial of DT120 for Generalized Anxiety Disorder (Voyage)

NCT06741228 · tracked via the Priya Life Science USA tracker
Sponsor
Definium Therapeutics US, Inc
Phase
Phase 3
Started
2024-12-11
Last updated
2026-09-25

Condition(s) studied

Generalized Anxiety Disorder

Investigational drug(s) / intervention(s)

PlaceboDT120 →

Placebo: A substance that is designed to have no therapeutic value

DT120: A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Study summary

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Generalized Anxiety Disorder - Voyage

Eligibility

Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12 — Baseline to Week 12
    The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Trial sites (34)

FacilityCityRegionStatus
Lighthouse Psychiatry Gilbert Arizona
Scottsdale Research Institute Scottsdale Arizona
Kadima Neuropsychiatry Institute La Jolla California
UCSF Department of Neurology San Francisco California
Psychedelic Science Institute Santa Monica California
Mountain View Denver Colorado
Clinical Neuroscience Solutions Inc. Jacksonville Florida
Segal Trials Lauderhill Florida
Atlanta Center for Medical Research Atlanta Georgia
iResearch Atlanta Decatur Georgia
CenExel iResearch, LLC Savannah Georgia
Uptown Research Institute Chicago Illinois
Adams Clinical Boston Boston Massachusetts
Adams Clinical Watertown Watertown Massachusetts
Hassman Research Institute Marlton New Jersey
Spectrum Neuroscience and Treatment Institute New York New York
Adams Clinical Harlem New York New York
New York State Psychiatric Institute (NYSPI) New York New York
Adams Clinical Bronx The Bronx New York
Cleveland Clinic Lutheran Hospital Cleveland Ohio
Summit Headlands LLC Portland Oregon
Scranton Medical Institute Moosic Pennsylvania
Adams Clinical Philadelphia Philadelphia Pennsylvania
Coastal Carolina Research Center North Charleston South Carolina
Clinical Neuroscience Solutions, Inc. Memphis Tennessee
University of Texas at Austin Austin Texas
Austin Clinical Trial Partners Austin Texas
BioBehavioral Research of Austin Austin Texas
FutureSearch Trials of Dallas, LLC Dallas Texas
Adams Clinical Dallas DeSoto Texas
Cedar Clinical Research Draper Utah
Inner Space Research Orem Utah
Memory Clinic Inc. Bennington Vermont
Seattle Neuropsychiatric Treatment Center Seattle Washington

More Definium Therapeutics US, Inc. trials in the USA

A Phase 3 Trial of DT120 for Major Depressive Disorder (Emerge) Active, not recruiting
A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend) Recruiting
A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama) Active, not recruiting
A Phase 2A Trial of DT402 for Autism Spectrum Disorder Recruiting

Other trials for the same condition

A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder Recruiting
RE104 Safety and Efficacy Study in Generalized Anxiety Disorder Recruiting
A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder Recruiting
A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder Recruiting
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06741228 on ClinicalTrials.gov ↗ ← All trials in the USA