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

NCT06809595 · tracked via the Priya Life Science Germany tracker

Sponsor

Definium Therapeutics US, Inc

Phase

Phase 3

Started

2025-01-29

Last updated

2026-09-04

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 - Panorama

Eligibility

Sex

ALL

Min age

18 Years

Max age

74 Years

Healthy volunteers

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 (36)

Facility	City	Region
Preferred Research Partners, Inc.	Little Rock	Arkansas
Psychedelic Science Institute	Los Angeles	California
West Los Angeles VA Medical Center	Los Angeles	California
Bradenton Research Center, Inc.	Bradenton	Florida
Clinical Neuroscience Solutions, Inc	Orlando	Florida
Atlanta Center for Medical Research	Atlanta	Georgia
Sheppard Pratt Health System	Towson	Maryland
Adams Clinical Boston	Boston	Massachusetts
Princeton Medical Institute	Princeton	New Jersey
University of Cincinnati Psychiatry- Anxiety Disorders Research Program	Cincinnati	Ohio
Neuro-Behavioral Clinical Research, Inc.	North Canton	Ohio
Austin Clinical Trial Partners	Austin	Texas
Core Clinical Research	Everett	Washington
A-shine s.r.o.	Pilsen	Czechia
Institut Neuropsychiatricke Pece (INEP)	Prague	Czechia
Psyon s.r.o.	Prague	Czechia
Cabinet Dr.Desbonnet : Résidence Saint Michel	Douai	France
Hôpital Conception, CIC Centre, bat néphrologie 3eme étage	Marseille	France
CMME	Paris	France
GHU Paris Psychiatrie et Neurosciences	Paris	France
Centre Hospitalier du Rouvray	Sotteville-lès-Rouen	France
Department of Psychiatry and Psychotherapy Campus Charité Mitte Charité Universitätsmedizin Berlin	Berlin	Germany
OVID Clinic Berlin	Berlin	Germany
Central Institute of Mental Health	Mannheim	Germany
Klinik für Psychiatrie und Psychotherapie, Abt: Allgemeine Psychiatrie und Psychotherapie	Tübingen	Germany
Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Poland
Department of Psychiatry, UCK	Gdansk	Poland
Department of Affective and Psychotic Disorders, Central Teaching Hospital, Medical University of Lodz	Lodz	Poland
Neuroclin Glasgow	Glasgow	United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, St. Nicholas Hospital	Gosforth	United Kingdom
4 Medical Clinical Solutions	London	United Kingdom
Clerkenwell Health - Baker Street	London	United Kingdom
Clerkenwell Health	London	United Kingdom
South London and Maudsley NHS Foundation Trust of The Maudsley Hospital	London	United Kingdom
4 Medical Clinical Solutions	Manchester	United Kingdom
St George's Community Health Centre	Sheffield	United Kingdom

Other trials for the same condition

A Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders 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 NCT06809595 on ClinicalTrials.gov ↗ ← All trials in Germany