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Study on ITI-1284 for Patients with Generalized Anxiety Disorder Who Did Not Respond Well to Previous Treatments

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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 a medication called ITI-1284, which is administered in the form of a tablet. The study will compare the effectiveness of two different doses of ITI-1284, 10 mg and 20 mg, taken once daily, against a placebo. The goal is to determine if ITI-1284 can help reduce anxiety symptoms in patients who have not responded well to previous treatments for GAD.

Participants in the study will take part over a period of six weeks. During this time, they will receive either ITI-1284 or a placebo. The study aims to assess changes in anxiety levels using a tool called the Hamilton Anxiety Rating Scale, which measures the severity of anxiety symptoms. The study will also look at other aspects of the participants' well-being, such as their overall quality of life and any changes in mood.

The purpose of this study is to evaluate the safety and effectiveness of ITI-1284 as a standalone treatment for GAD. By the end of the study, researchers hope to gather valuable information that could lead to improved treatment options for individuals living with this challenging 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.

  1. Step 1

    Initial visit

    Upon joining the study, you will have an initial visit where your eligibility will be confirmed. This includes checking your age, body mass index (BMI), and medical history related to generalized anxiety disorder (GAD).

    You will be asked to provide written informed consent, which means you agree to participate in the study after understanding all the details.

  2. Step 2

    Baseline assessment

    During this visit, your anxiety levels will be assessed using the Hamilton Anxiety Rating Scale (HAM-A) and other scales. This helps to establish a starting point for measuring changes during the study.

    You will be randomly assigned to receive either the study medication, ITI-1284, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active substance.

  3. Step 3

    Medication administration

    You will take the assigned tablet once daily. If you are in the group receiving ITI-1284, the dose will be either 10 mg or 20 mg. The tablet is taken sublingually, which means it is placed under the tongue to dissolve.

    This treatment will continue for a total of 6 weeks.

  4. Step 4

    Weekly assessments

    Throughout the 6-week period, you will have weekly assessments to monitor your progress. These assessments will include repeating the HAM-A scale and other evaluations to track changes in your anxiety symptoms.

    Your overall health and any side effects will also be monitored during these visits.

  5. Step 5

    Final assessment

    At the end of the 6-week period, a final assessment will be conducted. This will involve a comprehensive evaluation of your anxiety symptoms and overall experience during the study.

    The results will help determine the effectiveness and safety of ITI-1284 as a treatment for generalized anxiety disorder.

Who can join the trial?

11 criteria

  • 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 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 items related to anxious mood and tension.
    • A score of 4 or higher on the Clinical Global Impression-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 two approved treatments for Generalized Anxiety Disorder, such as paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone. These treatments must have been taken at the correct dose and for at least six weeks before the first visit.
    • 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 a failure rate of less than 1% per year when used correctly. Abstinence may be acceptable based on the doctor's judgment. Females who are permanently unable to have children or have not had a menstrual period for at least one year without another medical reason are exempt from this requirement. Females with only same-sex partners are also exempt.
    • Be able to follow study instructions and likely to attend all required visits.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with Generalized Anxiety Disorder (GAD) cannot participate. GAD is a condition where a person feels very anxious about many things over a long period.
  • Patients who have responded well to previous treatments for GAD are not eligible. This means if your current treatment is working well, you cannot join.
  • Patients who are not within the age range specified for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not willing or able to follow the study procedures cannot participate. This means you need to be able to attend all appointments and follow instructions.
  • Patients who are part of a vulnerable population, such as those who cannot give informed consent, are not eligible. This means if you cannot understand the study and agree to participate, you cannot join.
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Investigated drugs

ITI-1284 is a medication being tested to see if it can help people with Generalized Anxiety Disorder (GAD) who haven't had much success with other treatments. This medication is taken once a day and the study is looking at how well it can reduce anxiety symptoms over a period of six weeks. The goal is to see if it can make a noticeable difference in how patients feel compared to those who do not take the medication. The study measures its effectiveness by using a scale that rates anxiety levels, aiming to see a decrease in these scores by the end of the study period.

What is already known about the treatment

ITI-1284 – ITI-1284 is a medication currently being studied for its potential to help people with Generalized Anxiety Disorder (GAD) who have not responded well to other treatments. It is taken once a day in the form of a pill. The main goal of the ongoing clinical trial is to see how effective and safe ITI-1284 is compared to a placebo, by measuring changes in anxiety levels over six weeks. ITI-1284 works by affecting certain chemicals in the brain that are involved in anxiety, although the exact molecular mechanism is still being researched. It is classified as an investigational drug, meaning it is still being tested and is not yet approved for general medical use.

Investigated diseases

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 requires ongoing management.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516684-82-00Protocol codeITI-1284-302Estimated enrolment570 patientsSponsorIntra-Cellular Therapies Inc.

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