Phase 3 Trial of DT120 for Generalized Anxiety Disorder (Voyage)
This study is testing a new drug called DT120 for people with Generalized Anxiety Disorder (GAD). DT120 works by affecting a specific receptor in the brain called serotonin 2A (5-HT2A). Researchers want to see if DT120 can reduce anxiety symptoms compared to a placebo (a substance with no medicine in it). You might be able to join if you are 18 to 74 years old, have a GAD diagnosis, and a certain score on an anxiety scale (HAM-A total score of 20 or higher). The main goal is to measure changes in your anxiety symptoms after 12 weeks. The study is currently recruiting about 214 participants.
- Study design
- This is a Phase 3, double-blind study, meaning neither you nor your doctor will know if you are receiving DT120 or a placebo. It will involve up to 214 participants.
- What's involved
- You would participate in a 12-week treatment period, followed by a 40-week extension phase where you might receive DT120. Your anxiety levels will be measured at the beginning and after 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored and evaluated for 40 weeks after the initial 12-week treatment period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 3 Trial of DT120 for Generalized Anxiety Disorder (Voyage)
At a glance
Conditions
Where it's being run
34 sites across 18 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12Baseline 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.