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

Phase 2

Recruiting

• Conditions: Generalized Anxiety Disorder
• Interventions: Drug: ITI-1284 10 mg; Drug: ITI-1284 20 mg; Drug: Placebo

• Registration Number: NCT06701903
• Lead Sponsor: Intra-Cellular Therapies, Inc.

Brief Summary

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.

Detailed Description

The study will be conducted in 3 periods:

* 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.

Study Timeline

• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Study Start: 2024-11-21
• Study First Posted: 2024-11-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 570

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 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

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale (HAM-A)	Week 6	The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). It is comprised of 14 items that are rated on a 5-point scale ranging from 0

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression Scale-Severity (CGI-S)	Week 6	The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients)

Trial Locations

Locations (2)

Clinical Site; 🇺🇸 Bellevue, Washington, United States

Cinical Site; 🇺🇸 Orlando, Florida, United States