MM120 for Anxiety

(Panorama Trial)

Recruiting at -1 trial locations

Overseen By Mind Medicine, Inc. Clinical Trials Info Requests

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Mind Medicine, Inc.

Disqualifiers: Psychiatric disorders, Alcohol use, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug MM120 for anxiety?

The research on duloxetine, a drug similar to MM120, shows that early improvement in anxiety symptoms can predict better outcomes in patients with generalized anxiety disorder. This suggests that MM120 might also be effective if it shows early symptom improvement. ^{1 2 3 4 5}

How does the drug MM120 differ from other anxiety treatments?

MM120 is unique because it is a 5-HT2 receptor antagonist, which means it works by blocking specific serotonin receptors in the brain, potentially offering a different approach to treating anxiety compared to common treatments like SSRIs (selective serotonin reuptake inhibitors) that increase serotonin levels. ^{6 7 8 9 10}

Eligibility Criteria

Inclusion Criteria

Diagnosis of GAD per DSM-5

HAM-A Total Score ≥20

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

Exclusion Criteria

Any psychiatric disorder (other than generalized anxiety disorder)

Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)

Any clinically significant unstable illness

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

12-week randomized, double-blind, single dose administration period evaluating MM120 versus placebo

12 weeks

Open-label Extension

40-week open-label extension where participants are monitored and evaluated for potential retreatment with MM120

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MM120 (Other)

Participant Groups

Group I: Arm 3 - 100µg MM120 (LSD D-Tartrate) Experimental Treatment 1 Intervention

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

Group II: Arm 2 - 50µg MM120 (LSD D-Tartrate) Placebo Group 1 Intervention

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

Group III: Arm 1 - Placebo Placebo Group 1 Intervention

A substance that is designed to have no therapeutic value

Who Is Running the Clinical Trial?

Mind Medicine, Inc.

Lead Sponsor

Trials

8

Recruited

1,500+

Findings from Research

In a study of 668 patients with generalized anxiety disorder (GAD) treated with duloxetine over 9 to 10 weeks, early improvement in anxiety symptoms (measured by the Hamilton Anxiety Rating Scale) was strongly predictive of later treatment outcomes, including response and remission rates.

Patients showing significant improvement (over 80%) by week 2 had a 100% response rate by the end of the study, indicating that early response can help clinicians make timely decisions about continuing or adjusting treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early improvement during duloxetine treatment of generalized anxiety disorder predicts response and remission at endpoint. Pollack, MH., Kornstein, SG., Spann, ME., et al.[2022]

In an 8-week trial involving 73 adults with treatment-resistant generalized anxiety disorder (GAD), ziprasidone did not show a statistically significant difference in reducing anxiety compared to placebo, as measured by the Hamilton Anxiety Scale.

However, there was a trend indicating that ziprasidone may be more effective in patients who had stopped their previous ineffective medications (nonaugmented group) compared to those who continued other treatments, suggesting a potential interaction effect that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ziprasidone treatment of refractory generalized anxiety disorder: a placebo-controlled, double-blind study. Lohoff, FW., Etemad, B., Mandos, LA., et al.[2012]

Duloxetine significantly reduced social anxiety symptoms in individuals with generalized social anxiety disorder (GSAD) after 6 weeks of treatment, as shown by a decrease in the Liebowitz Social Anxiety Disorder Scale (LSAS) scores from 91.3 to 69.8.

While increasing the dose of duloxetine to 120 mg/day for those who did not achieve early remission showed a moderate effect size, it did not result in significantly better outcomes compared to continuing at 60 mg/day, indicating that higher doses may not provide additional benefits for symptom reduction or remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine for the treatment of generalized social anxiety disorder: a preliminary randomized trial of increased dose to optimize response. Simon, NM., Worthington, JJ., Moshier, SJ., et al.[2018]

In a study of 2,841 patients with major depressive disorder, duloxetine was found to be significantly more effective than placebo in improving depression symptoms for both anxious and nonanxious patients, with a greater change in Hamilton Depression Rating Scale (HAMD) scores.

The level of anxiety did not influence the effectiveness of duloxetine, as both anxious and nonanxious patients showed similar response and remission rates, indicating that duloxetine is a viable treatment option regardless of anxiety levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety does not predict response to duloxetine in major depression: results of a pooled analysis of individual patient data from 11 placebo-controlled trials. Nelson, JC.[2015]

Nefazodone, an antidepressant that blocks serotonin2 receptors and inhibits serotonin reuptake, was found to be effective in reducing anxiety and agitation symptoms in patients with major depression, showing significant improvements compared to placebo.

The study, which included 817 patients across six trials, demonstrated that nefazodone not only improved anxiety symptoms more rapidly than imipramine but also had a better safety profile, with only 5% of patients discontinuing treatment due to adverse effects compared to 17% for imipramine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response of anxiety and agitation symptoms during nefazodone treatment of major depression. Fawcett, J., Marcus, RN., Anton, SF., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Early improvement during duloxetine treatment of generalized anxiety disorder predicts response and remission at endpoint. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Ziprasidone treatment of refractory generalized anxiety disorder: a placebo-controlled, double-blind study. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Duloxetine for the treatment of generalized social anxiety disorder: a preliminary randomized trial of increased dose to optimize response. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Anxiety does not predict response to duloxetine in major depression: results of a pooled analysis of individual patient data from 11 placebo-controlled trials. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Response of anxiety and agitation symptoms during nefazodone treatment of major depression. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy trial of the 5-HT2 antagonist MDL 11,939 in patients with generalized anxiety disorder. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Testing anxious depression as a predictor and moderator of symptom improvement in major depressive disorder during treatment with escitalopram. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Therapeutic advances: paroxetine for the treatment of social anxiety disorder. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Are 5-HT2 antagonists endowed with anxiolytic properties in rodents? [2019]

10. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Observational multicenter study of efficacy of paroxetine filmcoated tablet in the treatment of anxiety disorder. [2022]