Study on ITI-1284 for Patients with Generalized Anxiety Disorder Not Responding to Current Treatment

What is this study about?

This clinical trial is focused on studying Generalized Anxiety Disorder (GAD), a condition characterized by excessive and persistent worry about various aspects of life. The study is testing a new treatment called ITI-1284, which is being used as an additional therapy for patients who have not responded well to their current GAD treatments. The medication ITI-1284 is administered in the form of a tablet and is taken once daily. The study will compare the effects of two different doses of ITI-1284 (10 mg and 20 mg) with a placebo to see if it can help reduce anxiety symptoms when used alongside existing GAD treatments.

The purpose of the study is to evaluate the effectiveness and safety of ITI-1284 as an additional treatment for GAD. Participants will be randomly assigned to receive either the medication or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will last for six weeks, during which time participants will continue their current GAD treatment while also taking the study medication or placebo. The main goal is to see if there is a change in anxiety levels from the start of the study to the end of the six weeks.

Throughout the study, participants will be monitored for any changes in their anxiety symptoms and overall well-being. The study aims to provide valuable information on whether ITI-1284 can be a helpful addition to existing treatments for those with GAD who have not found relief with their current medication. This research could potentially lead to new treatment options for individuals struggling with this challenging condition.

1 initial visit

Upon joining the study, you will have an initial visit where your eligibility will be confirmed. This includes meeting the criteria for **generalized anxiety disorder** and having an inadequate response to current treatment.

You will be asked to provide written informed consent, confirming your understanding and agreement to participate in the study.

2 baseline assessment

A baseline assessment will be conducted to evaluate your current anxiety levels using the **Hamilton Anxiety Rating Scale (HAM-A)**. This will help measure changes throughout the study.

Your current treatment for anxiety will be continued, and you will be asked to maintain the same dosing regimen for the duration of the study.

3 randomization and treatment

You will be randomly assigned to receive either the study medication **ITI-1284** or a **placebo**. The study medication will be administered as a sublingual tablet, which means it will dissolve under your tongue.

The dosage of **ITI-1284** will be either 10 mg or 20 mg, taken once daily for a period of 6 weeks.

4 weekly assessments

Throughout the 6-week period, you will have weekly assessments to monitor your progress. These assessments will include evaluations of your anxiety levels and any side effects you may experience.

The primary focus will be on changes in your **HAM-A** score, which measures the severity of your anxiety symptoms.

5 final assessment

At the end of the 6-week treatment period, a final assessment will be conducted to evaluate the overall effectiveness of the treatment.

This will include a review of your **HAM-A** score and other measures of your anxiety and general well-being.

Who Can Join the Study?

Provide written informed consent before starting any study procedures. This means you agree to participate after understanding the study details. If you cannot give consent yourself, you cannot join the study.
Be a male or female who is at least 18 years old.
Have a body mass index (BMI) between 19 and 40. BMI is a measure of body fat based on height and weight.
At the first visit, meet the criteria for moderate or severe Generalized Anxiety Disorder (GAD) as confirmed by a professional. This includes:
- A score of 22 or higher on the Hamilton Anxiety Rating Scale (HAM-A), which measures anxiety levels.
- A score of 2 or higher on HAM-A items for anxious mood and tension.
- A score of 4 or higher on the Clinical Global Impressions-Severity (CGI-S) scale, which assesses the severity of your condition.
- At the second visit, show less than 25% improvement in the HAM-A score from the first visit.
Have a history of inadequate response (less than 50% improvement) to at least one approved GAD treatment, such as paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone, taken at the correct dose and for at least 6 weeks.
Currently have an inadequate response to one of the approved GAD treatments listed above, taken at the correct dose and for at least 6 weeks before the first visit, and agree to continue this treatment during the study. The current treatment must be different from the one that previously did not work.
Be an outpatient, meaning you do not stay overnight in a hospital, and are expected to remain an outpatient throughout the study.
If you are of childbearing potential, agree to use a highly effective method of birth control during the study. This means using methods that have less than a 1% chance of failure per year. Abstinence may be acceptable based on the doctor’s judgment. If you are permanently unable to have children or are post-menopausal (no periods for at least one year), you do not need to use birth control.
Be able to follow study instructions and likely to attend all required visits.

Who Cannot Join the Study?

Patients who are not diagnosed with Generalized Anxiety Disorder (GAD) cannot participate.
Patients who are not currently receiving treatment for GAD cannot participate.
Patients who have a good response to their current GAD treatment cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not willing to take the study medication as directed cannot participate.
Patients who have any other medical condition that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to comply with the study procedures cannot participate.
Patients who have a history of substance abuse or dependency cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Ambulatory-Group Practice For Specialized Psychiatric Help Datamed Ltd.	Pleven	Bulgaria

Other Sites

Site Name	City	Country
Medical Center Hera EOOD	Sofia	Bulgaria
INEP medical s.r.o.	Prague	Czechia
Diagnostics-Consultancy Center Mladost M Varna OOD	Varna	Bulgaria
Medical Center Saint Naum EOOD	Sofia	Bulgaria
Medical Center Mentalcare Ltd.	Plovdiv	Bulgaria
Mehilaeinen Oy	Helsinki	Finland
Clintrial s.r.o.	Prague	Czechia
A-Shine s.r.o.	Plzen	Czechia
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD	Sofia	Bulgaria
Forbeli s.r.o.	Prague	Czechia
Medical Center Intermedica Ltd.	Sofia	Bulgaria
MłynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Łazarczyk	Bialystok	Poland
Filip Rybakowski Specjalistyczna Praktyka Lekarska	Poznan	Poland
Specjalistyczna Praktyka Lekarska Piotr Zalitacz	Gorlice	Poland
Ceukki Ffp Msxlzw Hhukem Pstoo Dgc Ixpf Tyiybe Buslkm Ekzd	Burgas	Bulgaria
Mteozf sbsful	Brno	Czechia
Mnebnro Crqrff Vrl Ofr	Targovishte	Bulgaria
Mnnlbhi Cqwubm Svomgbwobf Bwdgjciuyzy Oae	Blagoevgrad	Bulgaria
Cjqhkr Ffd Memmbq Henndd Rpju Eybs	Ruse	Bulgaria
Phkmlakfctc Sdsmrlifqmn Set z oupc	Bydgoszcz	Poland
Anaqavodi Njmvtwdunbvwicwhi Glihsbj Lwhzutnt Teutetwgu Cndhvhk Pxengofqhei Nfvgdapd	Torun	Poland
Czkfom Fpm Mmcxlp Hjeouj Vntgca Eakn	Vratsa	Bulgaria
Nuaqfbfizrmf Zmyyoh Oxpaso Pdfeztuibkxqxjd Mooqjn	Leszno	Poland
Shbqb Pmitwtsbnuwmrijf Om	Kuopio	Finland
Osfo Mpcwupuoum Og	Oulu	Finland
Saybda Tnboopewwrs Ob	Turku	Finland

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	02.12.2024
Czechia	Recruiting	02.12.2024
Finland	Not yet recruiting	02.12.2024
Poland	Recruiting	02.12.2024

Trial locations

Investigated drugs:

Iti-1284

ITI-1284 is a medication being tested to see if it can help people with Generalized Anxiety Disorder (GAD) who are not getting enough relief from their current treatment. In this study, ITI-1284 is given to patients in addition to their usual GAD medication. The goal is to find out if ITI-1284 can reduce anxiety symptoms more effectively than the current treatment alone. Patients will take ITI-1284 once a day, and the researchers will measure changes in anxiety levels over six weeks to see if it helps improve their condition.

Generalized Anxiety Disorder – Generalized Anxiety Disorder is a mental health condition characterized by persistent and excessive worry about various aspects of daily life. Individuals with this disorder often find it difficult to control their anxiety, which can interfere with their daily activities. The anxiety experienced is typically disproportionate to the actual situation and can persist for months or even longer. Symptoms may include restlessness, fatigue, difficulty concentrating, irritability, muscle tension, and sleep disturbances. The disorder tends to develop gradually and can fluctuate in intensity over time. It is a chronic condition that can affect individuals of all ages.

Trial ID:

2024-513302-56-00

Protocol code:

ITI-1284-301

NCT ID:

NCT06480383

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on ITI-1284 for Patients with Generalized Anxiety Disorder Not Responding to Current Treatment

What is this study about?

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