Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
Purpose
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.
Condition
- Generalized Anxiety Disorder
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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 (current GAD) as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline: - 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: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 milligram [mg], venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms.
Exclusion Criteria
- 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 Visit; - 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 (that is, at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ITI-1284 10mg |
ITI-1284 10 mg tablet, taken once daily, sublingual administration. |
|
|
Experimental ITI-1284 20mg |
ITI-1284 20 mg tablet, taken once daily, sublingual administration. |
|
|
Placebo Comparator Placebo |
Matching placebo tablet, taken once daily, sublingual administration |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- Intra-Cellular Therapies, Inc.