Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
NCT ID: NCT06701903
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
570 participants
INTERVENTIONAL
2024-11-21
2027-06-30
Brief Summary
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Detailed Description
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* Screening Period (up to 2 weeks) during which patient eligibility will be assessed and the washout of prohibited medications will occur;
* Double-blind Treatment Period (6 weeks) during which a total of approximately 570 patients are planned to be randomized in a 1:1:1 ratio to receive one of the 3 treatments (ITI-1284 10 mg, ITI-1284 20 mg, or placebo);
* Safety Follow-up Period (1 week) during which all patients will return for a safety follow-up visit approximately 1 week after the last dose of study drug.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ITI-1284 10mg
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
ITI-1284 10 mg
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
ITI-1284 20mg
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
ITI-1284 20 mg
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
Placebo
Matching placebo tablet, taken once daily, sublingual administration
Placebo
Matching placebo tablet, taken once daily, sublingual administration
Interventions
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ITI-1284 10 mg
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
ITI-1284 20 mg
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
Placebo
Matching placebo tablet, taken once daily, sublingual administration
Eligibility Criteria
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Inclusion Criteria
* 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 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 (at least the minimum GAD-approved dose per package insert) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms.
Exclusion Criteria
* 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 (ie, at least the minimum dose approved for GAD per package insert) and for an adequate duration (ie, at least 6 weeks).
18 Years
ALL
No
Sponsors
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Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Site
Birmingham, Alabama, United States
Clinical Site
Little Rock, Arkansas, United States
Clinical Site
Rogers, Arkansas, United States
Clinical Site
Culver City, California, United States
Clinical Site_2
Encino, California, United States
Clinical Site
Encino, California, United States
Clinical Site
Los Angeles, California, United States
Clinical Site
Oceanside, California, United States
Clinical Site
Sherman Oaks, California, United States
Clinical Site
Upland, California, United States
Clinical Site
Walnut Creek, California, United States
Clinical Site
Farmington, Connecticut, United States
Clinical Site
Gainesville, Florida, United States
Clinical Site
Miami, Florida, United States
Cinical Site
Orlando, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Decatur, Georgia, United States
Clinical Site
Chicago, Illinois, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Flowood, Mississippi, United States
Clinical Site
Brooklyn, New York, United States
Clinical Site
Buffalo, New York, United States
Clinical Site
Staten Island, New York, United States
Clinical Site
Columbus, Ohio, United States
Clinical Site
Oklahoma City, Oklahoma, United States
Clinical Site
Media, Pennsylvania, United States
Clinical Site
Dallas, Texas, United States
Clinical Site
Dallas, Texas, United States
Clinical Site
Bellevue, Washington, United States
Clinical Site
Blagoevgrad, , Bulgaria
Clinical Site
Kardzhali, , Bulgaria
Clinical Site
Pleven, , Bulgaria
Clinical Site
Plovdiv, , Bulgaria
Clinical Site
Rousse, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Targovishte, , Bulgaria
Clinical Site
Helsinki, , Finland
Clinical Site
Kuopio, , Finland
Clinical Site
Oulu, , Finland
Clinical Site
Tampere, , Finland
Clinical Site
Bialystok, , Poland
Clinical Site
Bydgoszcz, , Poland
Clinical Site
Gdansk, , Poland
Clinical Site
Leszno, , Poland
Clinical Site
Torun, , Poland
Clinical Site_2
Belgrade, , Serbia
Clinical Site_3
Belgrade, , Serbia
Clinical Site_4
Belgrade, , Serbia
Clinical Site
Belgrade, , Serbia
Clinical Site
Kovin, , Serbia
Clinical Site
Kragujevac, , Serbia
Clinical Site
Niš, , Serbia
Clinical Site
Novi Kneževac, , Serbia
Clinical Site
Bratislava, , Slovakia
Clinical Site
Rimavská Sobota, , Slovakia
Clinical Site
Svidník, , Slovakia
Clinical Site
Vranov nad Topľou, , Slovakia
Countries
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Central Contacts
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Other Identifiers
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ITI-1284-302
Identifier Type: -
Identifier Source: org_study_id
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