Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
NCT ID: NCT06480383
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
705 participants
INTERVENTIONAL
2024-08-05
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
NCT06701903
A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
NCT00236054
A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
NCT00236015
Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)
NCT00219349
Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.
NCT00214994
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Screening Period (up to 3 weeks) during which patient eligibility will be assessed and the washout of prohibited medications will occur.
* Double-blind Treatment Period (6 weeks) during which patients will 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ITI-1284 10mg
ITI-1284 10 mg
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
ITI-1284 20mg
ITI-1284 20 mg
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
Placebo
Placebo
Matching placebo tablet, taken once daily, sublingual administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Male or female patients ≥ 18 years of age;
3. 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:
1. HAM-A Total score of ≥ 22;
2. HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
3. CGI-S score of ≥ 4;
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 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, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;
5. 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 the minimum GAD-approved dose per package insert) and duration (ie, for at least 6 weeks prior to Screening) and agrees to continue the same dosing regimen for the duration of the study.
NOTE: The current GAD-approved treatment must be different from the GAD treatment identified as the historical failure.
Exclusion Criteria
1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
2. Bipolar Disorder;
2. MADRS total score \> 18 at Screening or Baseline;
3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
1. 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;
2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
3. At Screening or Baseline MADRS Item 10 score ≥ 5; or
4. The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator.
4. 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
Meet the organizations funding or collaborating on the study and learn about their roles.
Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Site
Chandler, Arizona, United States
Clinical Site
Encino, California, United States
Clinical Site
Glendale, California, United States
Clinical Site
Imperial, California, United States
Clinical Site
Lemon Grove, California, United States
Clinical Site
Oceanside, California, United States
Clinical Site
Orange, California, United States
Clinical Site
Redlands, California, United States
Clinical Site
San Diego, California, United States
Clinical Site
Farmington, Connecticut, United States
Clinical Site
Gainesville, Florida, United States
Clinical Site
Lauderhill, Florida, United States
Clinical Site
Maitland, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami Springs, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Atlanta, Georgia, United States
Clinical Site
Decatur, Georgia, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Ann Arbor, Michigan, United States
Clinical Site
Toms River, New Jersey, United States
Clinical Site
Brooklyn, New York, United States
Clinical Site
North Canton, Ohio, United States
Clinical Site
Oklahoma City, Oklahoma, United States
Clinical Site
Allentown, Pennsylvania, United States
Clinical Site
Media, Pennsylvania, United States
Clinical Site
Austin, Texas, United States
Clinical Site
Austin, Texas, United States
Clinical SIte
DeSoto, Texas, United States
Clinical Site
Plano, Texas, United States
Clinical Site
Bellevue, Washington, United States
Clinical Site
Blagoevgrad, , Bulgaria
Clinical Site
Burgas, , 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
Sofia, , Bulgaria
Clinical Site
Targovishte, , Bulgaria
Clinical Site
Varna, , Bulgaria
Clinical Site
Varna, , Bulgaria
Clinical Site
Vratsa, , Bulgaria
Clinical Site
Brno, , Czechia
Clinical Site
Pilsen, , Czechia
Clinical Site
Prague, , Czechia
Clinical Site
Prague, , Czechia
Clinical Site
Prague, , Czechia
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
Gorlice, , Poland
Clinical Site
Leszno, , Poland
Clinical Site
Poznan, , 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
Novi Kneževac, , Serbia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ITI-1284-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.