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Study on the Effects of MM120 (Lysergide) for Adults with Generalized Anxiety Disorder

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for Generalized Anxiety Disorder (GAD), a condition characterized by excessive and persistent worry about various aspects of life. The treatment being tested is called MM120, which contains the active substance lysergide, also known as lysergic acid diethylamide. The study will compare the effects of MM120 to a placebo to determine its effectiveness and safety in reducing anxiety symptoms in adults with GAD.

The purpose of the study is to evaluate how well a single dose of 100 micrograms of MM120 works in reducing anxiety symptoms compared to a placebo. The study is divided into two parts. Part A is a 12-week period where participants will receive either MM120 or a placebo without knowing which one they are taking. This is known as a double-blind study. After this, Part B is a 40-week open-label extension where all participants will have the opportunity to receive MM120, and the effects will be monitored over time.

Throughout the study, participants will be assessed at various time points to track changes in their anxiety levels and overall well-being. The study aims to provide valuable information on the potential benefits of MM120 for individuals with GAD, contributing to the understanding of new treatment options for this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
The trial begins with a **double-blind period** lasting 12 weeks. During this time, participants receive either a single dose of 100 micrograms of **MM120** or a **placebo**. The medication is administered as an **orodispersible tablet** for oral use.
Step 2
Monitoring and assessment
Throughout the 12-week double-blind period, changes in anxiety symptoms are monitored using the **Hamilton Anxiety Rating Scale (HAM-A)**. Assessments occur at weeks 1, 2, 4, 8, and 12 to evaluate the effectiveness of the treatment.
Additional assessments include the **Clinical Global Impression-Improvement (CGI-I) Scale**, **Clinical Global Impression-Severity (CGI-S) Scale**, **Patient Global Impression-Severity (PGI-S) Scale**, **Montgomery-Åsberg Depression Rating Scale (MADRS)**, **Work Productivity and Activity Impairment (WPAI)**, and **EuroQol 5-Dimension 5-Level (EQ-5D-5L)**.
Step 3
Evaluation of sexual functioning
During the double-blind period, changes in sexual functioning are evaluated using the **Changes in Sexual Functioning Questionnaire (CSFQ-14)**. This assessment helps determine the impact of the treatment on sexual health.
Step 4
Open-label extension
Following the double-blind period, participants enter a **40-week open-label extension**. During this phase, all participants receive **MM120** as needed, based on specific criteria for retreatment.
The need for additional doses is assessed, and the time to first treatment or discontinuation due to lack of efficacy is recorded.
Step 5
Ongoing assessments
Throughout the open-label period, ongoing assessments are conducted using the same scales as in the double-blind period. These include the **HAM-A**, **CGI-I**, **CGI-S**, **PGI-S**, **MADRS**, **WPAI**, **EQ-5D-5L**, and **CSFQ-14**.

Who can join the trial?

10 criteria

Participant must be between 18 and 74 years old at the time of signing the informed consent.
Participant must have an adult support person or caregiver who can monitor them throughout the study, accompany them to and from visits where the study drug is given, and agree to be in personal contact with the participant at least 3 days a week. This support person must be available throughout the clinical trial.
Participant must have a diagnosis of Generalized Anxiety Disorder (GAD) based on a clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI), which is a structured interview used to diagnose mental health conditions.
Participant must have a HAM-A Total Score of 20 or higher at Screening (Visit 1) and Baseline (Visit 2). The HAM-A is a questionnaire used to measure anxiety levels.
Participant must have scores of 2 or lower on items 1, 7, and 8 of the MADRS at Screening (Visit 1) and Baseline (Visit 2). The MADRS is a scale used to measure depression, and the participant must not meet criteria for a major depressive episode.
Participant must meet an independent assessment for eligibility.
Participant must have a Body Mass Index (BMI) between 18 and 38 kg/m² at Screening (Visit 1). BMI is a measure of body fat based on height and weight.
Participant must be male or female and willing to use medically acceptable forms of contraception, if applicable, for the duration of their participation.
Participant must be capable of giving signed informed consent, which includes agreeing to the requirements and restrictions listed in the informed consent form and in the study protocol.
Participant must be in an acceptable overall medical condition to participate in the study.

Who cannot join the trial?

5 criteria

Individuals who do not have Generalized Anxiety Disorder (GAD) cannot participate. GAD is a condition where a person feels very anxious or worried most of the time.
Participants must be within a certain age range, typically adults, to be eligible.
Both males and females can participate, but certain gender-specific conditions might exclude someone.
People who are considered part of a vulnerable population may be excluded. This term refers to groups who might need special protection, like children, pregnant women, or those with certain disabilities.
Individuals who do not meet the specific health requirements set by the study may be excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Central Institute of Mental Health
Mannheim, Germany
Responsive
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Lodz, Poland

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Investigated drugs

MM120 is an oral medication being studied for its potential to help reduce anxiety symptoms in adults with Generalized Anxiety Disorder (GAD). The trial aims to evaluate how effective and safe this medication is when compared to a placebo. Participants in the study will receive a single dose of MM120 to see if it can help manage their anxiety symptoms.

LYSERGIDE

What is already known about the treatment

MM120 – This medication is administered orally and is currently being studied in a Phase 3 clinical trial for its effectiveness in treating Generalized Anxiety Disorder (GAD). The trial aims to assess the efficacy and safety of MM120 compared to a placebo over a 12-week period, with an additional 40-week open-label extension. MM120 is designed to alleviate anxiety symptoms by targeting specific pathways in the brain, although the exact molecular mechanism is still under investigation. It is classified pharmacologically as an investigational drug, and its use is currently limited to clinical research settings.

Investigated diseases

Generalized Anxiety Disorder (GAD) – Generalized Anxiety Disorder is a mental health condition characterized by persistent and excessive worry about various aspects of life, such as work, health, or social interactions. Individuals with GAD often find it difficult to control their anxiety, which can interfere with daily activities. The disorder may manifest with physical symptoms like restlessness, fatigue, difficulty concentrating, irritability, muscle tension, and sleep disturbances. GAD tends to develop gradually and can vary in intensity over time. It is a chronic condition that may require ongoing management to help individuals cope with their symptoms.