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Active, not recruitingPhase 3

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

Key facts

Who runs it
Definium Therapeutics US, Inc.
Where
Atlanta, Austin, Bennington, Boston, Chicago, Cleveland, Dallas, Decatur, Denver, DeSoto, Draper, Gilbert, Jacksonville, La Jolla, Lauderhill, Marlton, Memphis, Moosic, New York, North Charleston, Orem, Philadelphia, Portland, San Francisco, Santa Monica, Savannah, Scottsdale, Seattle, The Bronx, and Watertown, United StatesSee the 34 sites
Trial code
Status
Active, not recruiting
Phase
Phase 3
People taking part
214 people enrolled
Started
11 Dec 2024
Expected to end
Apr 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Placebo
  • DT120
Record updated
25 September 2026

Who can take part

Age
18 years to 74 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Diagnosis of GAD per DSM-5
  • Male or female aged 18 to 74
  • HAM-A Total Score ≥20

Who cannot take part

  • Certain psychiatric disorders (other than generalized anxiety disorder)
  • First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
  • Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
  • Any clinically significant unstable illness

Where in United States

  • Atlanta Center for Medical ResearchAtlanta, United States
  • Austin Clinical Trial PartnersAustin, United States
  • BioBehavioral Research of AustinAustin, United States
  • University of Texas at AustinAustin, United States
  • Memory Clinic, Inc.Bennington, United States
  • Adams Clinical BostonBoston, United States
  • Uptown Research InstituteChicago, United States
  • Cleveland Clinic - Lutheran HospitalCleveland, United States
  • FutureSearch Trials of Dallas, LLCDallas, United States
  • iResearch AtlantaDecatur, United States
  • Mountain ViewDenver, United States
  • Adams Clinical DallasDeSoto, United States
  • Cedar Clinical ResearchDraper, United States
  • Lighthouse PsychiatryGilbert, United States
  • Clinical NeuroScience Solutions IncJacksonville, United States
  • Kadima Neuropsychiatry InstituteLa Jolla, United States
  • Segal TrialsLauderhill, United States
  • Hassman Research InstituteMarlton, United States
  • Clinical Neuroscience Solutions, Inc.Memphis, United States
  • Scranton Medical InstituteMoosic, United States
  • Adams Clinical HarlemNew York, United States
  • New York State Psychiatric Institute (NYSPI)New York, United States
  • Spectrum Neuroscience and Treatment InstituteNew York, United States
  • Coastal Carolina Research CenterNorth Charleston, United States
  • Inner Space ResearchOrem, United States
  • Adams Clinical PhiladelphiaPhiladelphia, United States
  • Summit Headlands LLCPortland, United States
  • UCSF Department of NeurologySan Francisco, United States
  • Psychedelic Science InstituteSanta Monica, United States
  • CenExel iResearch, LLCSavannah, United States
  • Scottsdale Research InstituteScottsdale, United States
  • Seattle Neuropsychiatric Treatment CenterSeattle, United States
  • Adams Clinical BronxThe Bronx, United States
  • Adams Clinical WatertownWatertown, United States

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Arm 1 - PlaceboPlacebo, for comparison

    A substance that is designed to have no therapeutic value

    Treatment: Placebo

  • Arm 2 - 100µg DT120Treatment being tested

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

    Treatment: DT120

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral DT120 Compared to Placebo in the Treatment of Adults With Generalized Anxiety Disorder - Voyage
Publications
Record updated
25 September 2026