Clinical Trials for Generalised Anxiety Disorder
There are currently 4 ongoing clinical trials investigating new treatments for Generalised Anxiety Disorder across several European countries. These studies are testing different investigational medications, including ITI-1284, MM120 (Lysergide), and Ulotaront, to help people who have not responded well to existing treatments or who need additional support in managing their anxiety symptoms.
Clinical trial locations
- Bulgaria
- Study on ITI-1284 for Patients with Generalized Anxiety Disorder Not Responding to Current Treatment
- Study on ITI-1284 for Patients with Generalized Anxiety Disorder Who Did Not Respond Well to Previous Treatments
- Study on the Effectiveness and Safety of Ulotaront for Adults with Generalized Anxiety Disorder
- Czechia
- Estonia
- Finland
- France
- Germany
- Poland
- Study on ITI-1284 for Patients with Generalized Anxiety Disorder Not Responding to Current Treatment
- Study on ITI-1284 for Patients with Generalized Anxiety Disorder Who Did Not Respond Well to Previous Treatments
- Study on the Effects of MM120 (Lysergide) for Adults with Generalized Anxiety Disorder
- Slovakia
- Spain
- Sweden
Study on ITI-1284 for Patients with Generalized Anxiety Disorder Who Did Not Respond Well to Previous Treatments
This trial is testing a new medication called ITI-1284 for people who have not found relief with previous anxiety treatments. The medication is taken as a tablet once daily, with researchers testing two different doses: 10 mg and 20 mg.
Who can participate: Adults aged 18 and older with moderate to severe anxiety who have tried at least two approved treatments without sufficient improvement. Participants must have a score of 22 or higher on the Hamilton Anxiety Rating Scale, a questionnaire that measures anxiety levels. They should also have a body mass index between 19 and 40.
Who cannot participate: People who have not been diagnosed with the condition, those who have responded well to previous treatments, and individuals who are pregnant, breastfeeding, or unable to follow the study procedures.
What the study involves: The trial lasts six weeks. Participants take ITI-1284 or a placebo daily, with their anxiety levels monitored using the Hamilton Anxiety Rating Scale and other assessment tools. The study measures how much anxiety symptoms decrease from the beginning to the end of the treatment period.
Study locations: Slovakia, Bulgaria, Poland
Study on the Effects of MM120 (Lysergide) for Adults with Generalized Anxiety Disorder
This study is evaluating MM120, which contains lysergide (also known as lysergic acid diethylamide), for treating anxiety symptoms. Unlike daily medications, this treatment involves a single dose of 100 micrograms given as a tablet that dissolves in the mouth.
Who can participate: Adults between 18 and 74 years old with a diagnosis of the condition confirmed through clinical assessment. Participants must have a Hamilton Anxiety Rating Scale score of 20 or higher and need an adult support person who can monitor them throughout the study and accompany them to treatment visits.
Who cannot participate: People without the condition, those outside the specified age range, pregnant or breastfeeding women, and individuals with certain other mental health conditions such as major depression.
What the study involves: The trial has two parts. Part A lasts 12 weeks, during which participants receive either MM120 or a placebo without knowing which one they are taking. Part B is a 40-week extension where all participants can receive MM120 if needed. Throughout both parts, anxiety levels are measured regularly using standardized scales, and participants are monitored for any changes in symptoms or side effects.
Study locations: Poland, Czechia, France, Germany
Study on ITI-1284 for Patients with Generalized Anxiety Disorder Not Responding to Current Treatment
This trial is testing whether ITI-1284 can help people who are already taking medication for anxiety but are not getting enough relief. The study medication is taken in addition to the participant’s current treatment.
Who can participate: Adults aged 18 and older who are currently taking an approved anxiety medication but still have significant symptoms. Participants must have tried at least one other approved treatment in the past without success. They need a Hamilton Anxiety Rating Scale score of 22 or higher and a body mass index between 19 and 40.
Who cannot participate: People whose current anxiety treatment is working well, those not currently receiving treatment, pregnant or breastfeeding women, individuals with substance abuse history, and those participating in other clinical trials.
What the study involves: Participants continue taking their current anxiety medication while also taking ITI-1284 or a placebo once daily for six weeks. The study tests two doses of ITI-1284: 10 mg and 20 mg. Regular assessments track changes in anxiety levels and overall well-being.
Study locations: Bulgaria, Poland, Czechia
Study on the Effectiveness and Safety of Ulotaront for Adults with Generalized Anxiety Disorder
This study is investigating Ulotaront (also known as SEP-363856), a medication taken as a daily tablet. The dosage is flexible, ranging from 50 to 75 mg per day, and can be adjusted based on how each participant responds.
Who can participate: Males and females between 18 and 65 years old with a confirmed diagnosis according to the DSM-5 criteria, which is a manual healthcare professionals use to diagnose mental disorders. Participants must be willing and able to follow the study procedures and understand verbal and written instructions.
Who cannot participate: People without a diagnosis of the condition and those outside the specified age range.
What the study involves: Participants are randomly assigned to receive either Ulotaront or a placebo. Regular visits are scheduled to monitor progress and any side effects. Anxiety levels are assessed using the Hamilton Anxiety Rating Scale and other evaluation tools to track changes from the beginning of the study. At the end of the trial, researchers compare the results to the baseline measurements to determine the treatment’s effectiveness.
Study locations: France, Sweden, Spain, Bulgaria, Slovakia, Estonia, Finland
Summary
These four clinical trials represent important research into new treatment options for Generalised Anxiety Disorder. The studies are spread across multiple European countries, with Poland, Bulgaria, and Czechia hosting multiple trials. This geographical distribution provides opportunities for patients in various locations to access experimental treatments.
Two of the trials focus on ITI-1284, examining its use both as a standalone treatment and as an add-on therapy for people not responding to current medications. The other studies investigate MM120 (Lysergide) with its unique single-dose approach, and Ulotaront with flexible dosing. All trials use the Hamilton Anxiety Rating Scale as a primary tool to measure treatment effectiveness.
Most of these studies specifically target individuals who have not found adequate relief with existing treatments, addressing an important unmet need in anxiety care. The trials range from 6 to 12 weeks for their main phases, with one study offering an extended 40-week follow-up period.
