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 - Panorama

Official Summary

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 - Panorama

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 74 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 250 participants

Study Arms

• Arm 1 - Placebo (PLACEBO_COMPARATOR)
  A substance that is designed to have no therapeutic value
• Arm 2 - 50µg MM120 (LSD D-Tartrate) (SHAM_COMPARATOR)
  A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
• Arm 3 - 100µg MM120 (LSD D-Tartrate) (EXPERIMENTAL)
  A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Interventions

• OTHER: Placebo — A substance that is designed to have no therapeutic value
• DRUG: MM120 (LSD D-Tartrate) — A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Primary Outcomes

• Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12 (Baseline to Week 12)

Secondary Outcomes

• Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1 (Week 8, Week 4, Week 2, and Week 1)
• HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period (Baseline to Week 12)
• HAM-A remission (total score ≤7) at each timepoint assessed during the 12-week double-blind treatment period (Baseline to Week 12)
• Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period (Day 2 to Week 12)
• Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score (Baseline to Week 12)

Eligibility Criteria

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

Trial Locations

• Preferred Research Partners, Inc., Little Rock, Arkansas, United States
• Psychedelic Science Institute, Los Angeles, California, United States
• West Los Angeles VA Medical Center, Los Angeles, California, United States
• Bradenton Research Center, Inc., Bradenton, Florida, United States
• Clinical Neuroscience Solutions, Inc, Orlando, Florida, United States
• Atlanta Center for Medical Research, Atlanta, Georgia, United States
• Sheppard Pratt Health System, Towson, Maryland, United States
• Adams Clinical Boston, Boston, Massachusetts, United States
• Princeton Medical Institute, Princeton, New Jersey, United States
• University of Cincinnati Psychiatry- Anxiety Disorders Research Program, Cincinnati, Ohio, United States
• ...and 10 more locations

More Generalized Anxiety Disorder Trials

View all Generalized Anxiety Disorder clinical trials