RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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 MM120 Compared to Placebo in the Treatment of Adults With Generalized Anxiety Disorder - Voyage

Quick Facts

Study Start:2024-12-11
Study Completion:2027-06-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06741228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 74 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female: must be between 18 (or the legal age of consent in the jurisdiction in which the study is taking place) and 74 years of age inclusive, at the time of signing the informed consent.
  2. 2. Diagnosis of GAD per DSM-5.
  3. 3. HAM-A Total Score ≥20.
  1. 1. Any psychiatric disorder (other than generalized anxiety disorder).
  2. 2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder.
  3. 3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine).
  4. 4. Any clinically significant unstable illness.

Contacts and Locations

Study Contact

Mind Medicine Clinical Trials Info Requests
CONTACT
332-282-0479
clinicaltrials@mindmed.co

Study Locations (Sites)

Mountain View
Denver, Colorado, 80209
United States
Segal Trials
Lauderhill, Florida, 33319
United States
iResearch Atlanta
Decatur, Georgia, 30030
United States
Uptown Research Institute
Chicago, Illinois, 60640
United States
Adams Clinical
Watertown, Massachusetts, 02472
United States
BioBehavioral Research of Austin
Austin, Texas, 78759
United States
Cedar Clinical Research
Draper, Utah, 84020
United States

Collaborators and Investigators

Sponsor: Mind Medicine, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-11
Study Completion Date2027-06-03

Study Record Updates

Study Start Date2024-12-11
Study Completion Date2027-06-03

Terms related to this study

Additional Relevant MeSH Terms

  • Generalized Anxiety Disorder