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Not recruiting
Phase 3

MM120

Sponsor:

Definium Therapeutics US, Inc.

Code:

NCT06809595

Conditions

Generalized Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

MM120 (LSD D-Tartrate)

Study Details

Brief 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

Conditions

Generalized Anxiety Disorder

Study ID

NCT06809595

Start date

Jan 29, 2025

Status verified date

May, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Arm 1 - Placebo

A substance that is designed to have no therapeutic value

sham comparator: Arm 2 - 50µg MM120 (LSD D-Tartrate)

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

experimental: Arm 3 - 100µg MM120 (LSD D-Tartrate)

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

Interventions

Placebo

A substance that is designed to have no therapeutic value

MM120 (LSD D-Tartrate)

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

Primary outcome measure

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

Central Contacts and Locations

More Information

Sponsor

Definium Therapeutics US, Inc.

Last update posted

May 1, 2026

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Definium Therapeutics US, Inc. on 2026-05-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.