Active not recruitingPHASE3INTERVENTIONAL

A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)

This study, called Panorama, is looking into a new treatment, MM120, for adults living with Generalised Anxiety Disorder (GAD). Researchers want to see if MM120 can effectively lessen anxiety symptoms. Participants will be given either MM120 or a placebo (a dummy pill with no active medicine) in a single dose, and then carefully watched over 12 weeks. After this, there's an option for a longer, open-label period where everyone might receive MM120. The study is for people aged 18 to 74 who have been diagnosed with GAD and meet certain anxiety symptom levels. It aims to gather important information safely, with healthcare professionals monitoring participants throughout. The goal is to find new ways to help people manage GAD.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Definium Therapeutics US, Inc.

Enrolment target

245

Start

29 Jan 2025

Estimated completion

01 May 2027

Generalized Anxiety Disorder

What is this study about?

Imagine feeling worried or anxious a lot of the time, even when there's no clear reason. This is what life can be like for someone with Generalised Anxiety Disorder, or GAD. It can make everyday tasks feel really difficult. Researchers are always looking for better ways to help people manage these feelings, and that's why they are conducting a new study called Panorama.

This study is designed to test a new medicine, MM120, to see how well it works compared to a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps doctors fairly assess if the new medicine is actually making a difference. The study will involve giving participants one dose of either MM120 or the placebo and then carefully observing how they feel over several weeks.

After this first part, there's a chance for participants to continue in the study for a longer period, where they might all receive the active medicine. The main goal is to find out if MM120 can safely and effectively reduce the symptoms of GAD, potentially offering a new option for people who struggle with this condition.

Key takeaways

This study explores a new medicine (MM120) for Generalised Anxiety Disorder (GAD).
It compares MM120 to a dummy pill (placebo) to see if it helps anxiety.
Participation involves one dose of medicine/placebo, followed by regular check-ups.
People aged 18-74 with a GAD diagnosis might be eligible.
The study lasts about a year, with options for active treatment later.
Your health and safety are closely monitored throughout.

Who may be eligible?

To join this study, people need to be adults aged between 18 and 74 years old. They must have a diagnosis of Generalised Anxiety Disorder (GAD) that has been confirmed by a doctor, and their anxiety symptoms should be at a certain level. People with very mild anxiety might not be suitable for this particular study.

However, some people won't be able to take part. This includes individuals who have other specific mental health conditions apart from GAD, or those with a close family member who has a history of certain serious mental health issues like psychosis or bipolar disorder. Also, people with current problems with alcohol or drug use (unless it's just nicotine or caffeine) or those with any serious uncontrolled health conditions would not be eligible. This is to make sure the study is as safe as possible for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 74 years old?
Have you been diagnosed with Generalised Anxiety Disorder (GAD)?
Are your anxiety symptoms currently at a moderate-to-severe level?
Do you have a personal or family history of psychosis or bipolar disorder?
Do you currently have issues with alcohol or drug use (other than nicotine/caffeine)?
Do you have any other serious uncontrolled medical conditions?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first have some health checks to make sure it's right for you. If you qualify, you'll be randomly assigned to either receive one dose of the study medicine (MM120) or a placebo (a dummy pill).

Over the next 12 weeks, you'll have regular appointments where doctors will check how you're feeling and how your anxiety symptoms are changing. They might ask you questions or have you complete questionnaires. After these 12 weeks, there's an optional longer period of up to 40 weeks where you might have the chance to receive the active study medicine. Throughout the entire study, which could last about a year, your health and well-being will be closely monitored by the study team.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment for your GAD symptoms. However, it's also possible that you might receive a placebo and not the active medicine, meaning your anxiety might not improve, or could even worsen. As with any medicine, MM120 might have side effects, and the study team will discuss these with you. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (37)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Preferred Research Partners, Inc.
Verified postcode
Little Rock, United States
Psychedelic Science Institute
Verified postcode
Los Angeles, United States
West Los Angeles VA Medical Center
Verified postcode
Los Angeles, United States
Bradenton Research Center, Inc.
Verified postcode
Bradenton, United States
Clinical Neuroscience Solutions, Inc
Verified postcode
Orlando, United States
Atlanta Center for Medical Research
Verified postcode
Atlanta, United States
Sheppard Pratt Health System
Verified postcode
Towson, United States
Adams Clinical Boston
Verified postcode
Boston, United States
Princeton Medical Institute
Verified postcode
Princeton, United States
University of Cincinnati Psychiatry- Anxiety Disorders Research Program
Verified postcode
Cincinnati, United States
Neuro-Behavioral Clinical Research, Inc.
Verified postcode
North Canton, United States
Austin Clinical Trial Partners
Verified postcode
Austin, United States

Common questions

What is Generalised Anxiety Disorder (GAD)?

GAD is when someone feels excessively worried or anxious about many different things, most days of the week, for several months.

What is a placebo?

A placebo is a 'dummy' pill that looks like the real medicine but contains no active ingredients. It helps researchers fairly compare the new medicine's effects.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study team will know if you're receiving MM120 or the placebo during the first 12 weeks.

How long will the study last if I join?

The first part of the study lasts 12 weeks, and there's an optional extension that could last up to 40 more weeks, making the total around a year.

Can I leave the study whenever I want?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.