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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT06701903

Run by

Intra-Cellular Therapies, Inc.

People needed

570

Starts

2024-11-21

Expected to finish

2027-06-01

Last updated by the study team

2026-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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.

You may not qualify 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 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).

Where it is running

• Clinical Site — Blagoevgrad, Bulgaria (enrolling)
• Clinical Site — Plovdiv, Bulgaria (enrolling)
• Clinical Site — Media, Pennsylvania, United States (enrolling)
• Clinical Site — Bellevue, Washington, United States (enrolling)
• Clinical Site — Kardzhali, Bulgaria (enrolling)
• Clinical Site — Pleven, Bulgaria (enrolling)
• Clinical Site — Birmingham, Alabama, United States (enrolling)
• Clinical Site — Oklahoma City, Oklahoma, United States (enrolling)
• Clinical Site — Little Rock, Arkansas, United States (enrolling)
• Clinical Site — Dallas, Texas, United States (enrolling)
• Clinical Site — Rogers, Arkansas, United States (enrolling)
• Clinical Site — Encino, California, United States (enrolling)
• Clinical Site — Miami, Florida, United States (enrolling)
• Clinical Site — Los Angeles, California, United States (enrolling)
• Clinical Site — Oceanside, California, United States (enrolling)
• Clinical Site — Culver City, California, United States (enrolling)
• Clinical Site — Decatur, Georgia, United States (enrolling)
• Clinical Site — Sherman Oaks, California, United States (enrolling)
• Clinical Site_2 — Encino, California, United States (enrolling)
• Clinical Site — Flowood, Mississippi, United States (enrolling)
• Clinical Site — Brooklyn, New York, United States (enrolling)
• Clinical Site — Walnut Creek, California, United States (enrolling)
• Clinical Site — Staten Island, New York, United States (enrolling)
• Clinical Site — Farmington, Connecticut, United States (enrolling)
• Clinical Site — Rousse, Bulgaria (enrolling)

Full record on ClinicalTrials.gov

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