Generalized Anxiety Disorder study: ITI-1284
Official title Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
ClinicalTrials.gov ID: NCT06480383
What this study is testing
What is ITI-1284 10 mg?
an investigational sublingual tablet being studied as an adjunctive treatment 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
- This study aims to find out if adding ITI-1284 to existing treatment improves symptoms, and to check for any side effects.
- Who it's for
- The study is looking for adults with generalized anxiety disorder whose current treatment has not fully worked.
- What's involved
- Participants will take a daily pill (either the new medicine or a sugar pill) along with their usual anxiety treatment and attend regular check-ups.
- Time commitment
- The study involves regular visits over a period of time to monitor how the body reacts to the medicine.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Provide written informed consent before the initiation of any study specific procedures;
- Male or female patients ≥ 18 years of age;
- HAM-A Total score of ≥ 22;
- HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
- CGI-S score of ≥ 4;
You likely can't join if
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
- Bipolar Disorder;
- MADRS total score \> 18 at Screening or Baseline;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
- At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the...
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
See the full eligibility criteria
- Provide written informed consent before the initiation of any study specific procedures;
- Male or female patients ≥ 18 years of age;
- HAM-A Total score of ≥ 22;
- HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
- CGI-S score of ≥ 4;
- History of inadequate response (\< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire [ATRQ] for GAD) to at least 1 GAD-approved treatment (ie, one of the...
- Currently having an inadequate response to one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least a minimum total daily dose...
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
- Bipolar Disorder;
- MADRS total score \> 18 at Screening or Baseline;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
- At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening...
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
- At Screening or Baseline MADRS Item 10 score ≥ 5; or
- The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator.
- Lifetime history of failure to respond to \> 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (at least a minimum total daily dose of...
The study team makes the final eligibility decision.
Where it is enrolling
- Glendale, California, United States
- Imperial, California, United States
- Lemon Grove, California, United States
- Oceanside, California, United States
- Orange, California, United States
- Redlands, California, United States
- Miami, Florida, United States
- Miami Springs, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Ann Arbor, Michigan, United States
- Toms River, New Jersey, United States
- Brooklyn, New York, United States
- North Canton, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Allentown, Pennsylvania, United States
- Media, Pennsylvania, United States
- Austin, Texas, United States
- Plano, Texas, United States
- Bellevue, Washington, United States
+ 25 more site(s).
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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Glendale, California, United States; Imperial, California, United States; Lemon Grove, California, United States; Oceanside, California, United States; Orange, California, United States; Redlands, California, United States and 39 more locations. 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.