BridgeMD
New treatment option for Generalized Anxiety Disorder
Official title Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
ClinicalTrials.gov ID: NCT06701903
What this study is testing
What is ITI-1284 10 mg?
ITI-1284 10 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential 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 is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.
- 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
Ages 18 and older
You may be able to join if
- Provide written informed consent before the initiation of any study specific procedures;
- At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or...
- 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
- Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:
- 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...
See the full eligibility criteria
- Provide written informed consent before the initiation of any study specific procedures;
- At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD as confirmed by the Investigator or Sponsor-approved rater...
- 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 2 of the following GAD-approved treatments...
- Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:
- 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 (ie, at least the minimum dose approved for...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Culver City, California, United States
- Encino, California, United States
- Los Angeles, California, United States
- Oceanside, California, United States
- Sherman Oaks, California, United States
- Upland, California, United States
- Walnut Creek, California, United States
- Farmington, Connecticut, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Decatur, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Flowood, Mississippi, United States
- Brooklyn, New York, United States
+ 32 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 - 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?
Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Culver City, California, United States; Encino, California, United States; Los Angeles, California, United States and 46 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.