Generalized Anxiety Disorder study: ITI-1284
Official title A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
ClinicalTrials.gov ID: NCT07807865
What this study is testing
What is ITI-1284?
ITI-1284 is an investigational sublingual medicine being studied for generalized anxiety disorder.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see how safe and well tolerated ITI‑1284 is over a long period, both by itself and when added to other medicines.
- Who it's for
- Adults with generalized anxiety disorder who have not responded to previous treatments.
- What's involved
- Participants will receive ITI‑1284 (alone or with other drugs) and will have regular visits and medical checks to monitor safety and side effects.
- Time commitment
- The study lasts several months and requires multiple clinic visits for medication administration and safety monitoring.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provide written informed consent before the initiation of any study specific procedures
- Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study
- Male or female of childbearing potential and agrees to use a highly effective method of birth control from the time informed consent is provided...
- Ability to follow study instructions and likely to complete all required visits
- In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302)
You likely can't join if
- for Roll-over participants
- In the opinion of the Investigator, the participant has a significant risk for suicidal behavior during the course of her/his participation in the...
- The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline
- Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the...
- The participant has any other condition that may be detrimental to the participant if they participate in the study
- In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study Exclusion...
See the full eligibility criteria
- Provide written informed consent before the initiation of any study specific procedures
- Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study
- Male or female of childbearing potential and agrees to use a highly effective method of birth control from the time informed consent is provided until 30 days after the last dose of ITI-1284 for females and 90 days...
- Ability to follow study instructions and likely to complete all required visits
- In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302)
- Provide written informed consent before the initiation of any study-specific procedures
- Male or female participants greater than or equal to (\>=) 18 years of age
- Has a body mass index (BMI) of 19-40 kilogram per meter squared (kg/m\^2), inclusive
- At screening, meet diagnostic and statistical manual of mental disorders, fifth edition, text revision (DSM-5-TR) diagnostic criteria for moderate or severe generalized anxiety disorder (GAD) (current GAD) as confirmed...
- Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study
- for Roll-over participants
- In the opinion of the Investigator, the participant has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or...
- The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline
- Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the lead-in study that are considered clinically significant and preclude safe...
- The participant has any other condition that may be detrimental to the participant if they participate in the study
- In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study Exclusion criteria for De-novo participants
- Within the participant's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder
- Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders; b. moderate or severe alcohol or substance use disorders; c.
- MADRS total score greater than (\>) 18 at screening or baseline
- The participant has received electroconvulsive therapy (ECT) or vagal nerve stimulation within the past 5 years, or repetitive trans cranial magnetic stimulation within the last 2 years, or had a failure in response to...
- The participant has known hypersensitivity or intolerance to ITI-007 (lumateperone), ITI-1284, or to any of the excipients
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Miami, Florida, United States
- Brooklyn, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Miami, Florida, United States; Brooklyn, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.