RECRUITING

Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment

Quick Facts

Study Start:2024-11
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06701903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provide written informed consent before the initiation of any study specific procedures;
  2. * 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:
  3. * HAM-A Total score of ≥ 22;
  4. * HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
  5. * CGI-S score of ≥ 4;
  6. * 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.
  1. * Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:
  2. * Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
  3. * Bipolar Disorder;
  4. * MADRS total score \> 18 at Screening or Baseline;
  5. * In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
  6. * 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;
  7. * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
  8. * At Screening or Baseline MADRS Item 10 score ≥ 5; or
  9. * The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator;
  10. * 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).

Contacts and Locations

Study Contact

ITI Clinical Trials
CONTACT
6464409333
ITCIClinicalTrials@itci-inc.com

Study Locations (Sites)

Clinical Site
Little Rock, Arkansas, 72211
United States
Clinical Site
Culver City, California, 90230
United States
Clinical Site
Encino, California, 91316
United States
Clinical Site
Los Angeles, California, 90024
United States
Clinical Site
Oceanside, California, 92056
United States
Clinical Site
Gainesville, Florida, 32607
United States
Clinical Site
Miami, Florida, 33176
United States
Cinical Site
Orlando, Florida, 32803
United States
Clinical Site
Decatur, Georgia, 30030
United States
Clinical Site
Boston, Massachusetts, 02131
United States
Clinical Site
Oklahoma City, Oklahoma, 73116
United States
Clinical Site
Media, Pennsylvania, 19063
United States
Clinical Site
Dallas, Texas, 75231
United States
Clinical Site
Dallas, Texas, 75243
United States
Clinical Site
Bellevue, Washington, 98007
United States

Collaborators and Investigators

Sponsor: Intra-Cellular Therapies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11
Study Completion Date2027-06

Study Record Updates

Study Start Date2024-11
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Generalized Anxiety Disorder