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

NCT06701903 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ITI-1284-302
• Study Type: interventional
• Target: 570
• Locations: 6 countries
• Sites: 60

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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Rating Scale (HAM-A)

  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

  Week 6

Secondary Outcomes (1)

• Clinical Global Impression Scale-Severity (CGI-S)

  Week 6

Study Arms (3)

ITI-1284 10mg

EXPERIMENTAL

ITI-1284 10 mg tablet, taken once daily, sublingual administration.

Drug: ITI-1284 10 mg

ITI-1284 20mg

EXPERIMENTAL

ITI-1284 20 mg tablet, taken once daily, sublingual administration.

Drug: ITI-1284 20 mg

Placebo

PLACEBO COMPARATOR

Matching placebo tablet, taken once daily, sublingual administration

Drug: Placebo

Interventions

ITI-1284 10 mg DRUG

ITI-1284 10 mg tablet, taken once daily, sublingual administration.

ITI-1284 10mg

ITI-1284 20 mg DRUG

ITI-1284 20 mg tablet, taken once daily, sublingual administration.

ITI-1284 20mg

Placebo DRUG

Matching placebo tablet, taken once daily, sublingual administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (60)

Clinical Site

Birmingham, Alabama, 35294, United States

RECRUITING

Clinical Site

Little Rock, Arkansas, 72211, United States

RECRUITING

Clinical Site

Rogers, Arkansas, 72758, United States

RECRUITING

Clinical Site

Culver City, California, 90230, United States

RECRUITING

Clinical Site_2

Encino, California, 91316, United States

RECRUITING

Clinical Site

Encino, California, 91316, United States

RECRUITING

Clinical Site

Los Angeles, California, 90025, United States

RECRUITING

Clinical Site

Oceanside, California, 92056, United States

RECRUITING

Clinical Site

Sherman Oaks, California, 91403, United States

RECRUITING

Clinical Site

Upland, California, 91786, United States

ACTIVE NOT RECRUITING

Clinical Site

Walnut Creek, California, 94596, United States

RECRUITING

Clinical Site

Farmington, Connecticut, 06030, United States

RECRUITING

Clinical Site

Gainesville, Florida, 32607, United States

ACTIVE NOT RECRUITING

Clinical Site

Miami, Florida, 33176, United States

RECRUITING

Cinical Site

Orlando, Florida, 32803, United States

ACTIVE NOT RECRUITING

Clinical Site

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Clinical Site

Tampa, Florida, 33613, United States

NOT YET RECRUITING

Clinical Site

Decatur, Georgia, 30030, United States

RECRUITING

Clinical Site

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Clinical Site

Boston, Massachusetts, 02131, United States

ACTIVE NOT RECRUITING

Clinical Site

Flowood, Mississippi, 39232, United States

RECRUITING

Clinical Site

Brooklyn, New York, 11235, United States

RECRUITING

Clinical Site

Buffalo, New York, 14215, United States

ACTIVE NOT RECRUITING

Clinical Site

Staten Island, New York, 10314, United States

RECRUITING

Clinical Site

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Clinical Site

Oklahoma City, Oklahoma, 73116, United States

RECRUITING

Clinical Site

Media, Pennsylvania, 19063, United States

RECRUITING

Clinical Site

Dallas, Texas, 75231, United States

NOT YET RECRUITING

Clinical Site

Dallas, Texas, 75243, United States

RECRUITING

Clinical Site

Bellevue, Washington, 98007, United States

RECRUITING

Clinical Site

Blagoevgrad, 2700, Bulgaria

RECRUITING

Clinical Site

Kardzhali, 6600, Bulgaria

RECRUITING

Clinical Site

Pleven, 5800, Bulgaria

RECRUITING

Clinical Site

Plovdiv, 4004, Bulgaria

RECRUITING

Clinical Site

Rousse, 7003, Bulgaria

RECRUITING

Clinical Site

Sofia, 1408, Bulgaria

RECRUITING

Clinical Site

Sofia, 1510, Bulgaria

RECRUITING

Clinical Site

Sofia, 1680, Bulgaria

RECRUITING

Clinical Site

Targovishte, 7700, Bulgaria

RECRUITING

Clinical Site

Helsinki, 00100, Finland

NOT YET RECRUITING

Clinical Site

Kuopio, 70110, Finland

NOT YET RECRUITING

Clinical Site

Oulu, 90100, Finland

NOT YET RECRUITING

Clinical Site

Tampere, 33210, Finland

NOT YET RECRUITING

Clinical Site

Bialystok, 15272, Poland

RECRUITING

Clinical Site

Bydgoszcz, 85-080, Poland

RECRUITING

Clinical Site

Gdansk, 80283, Poland

RECRUITING

Clinical Site

Leszno, 64100, Poland

RECRUITING

Clinical Site

Torun, 87100, Poland

RECRUITING

Clinical Site_2

Belgrade, 11000, Serbia

RECRUITING

Clinical Site_3

Belgrade, 11000, Serbia

RECRUITING

Clinical Site_4

Belgrade, 11000, Serbia

RECRUITING

Clinical Site

Belgrade, 11000, Serbia

RECRUITING

Clinical Site

Kovin, 26220, Serbia

RECRUITING

Clinical Site

Kragujevac, 34000, Serbia

RECRUITING

Clinical Site

Niš, 18000, Serbia

RECRUITING

Clinical Site

Novi Kneževac, 23330, Serbia

RECRUITING

Clinical Site

Bratislava, 82101, Slovakia

RECRUITING

Clinical Site

Rimavská Sobota, 97901, Slovakia

RECRUITING

Clinical Site

Svidník, 08901, Slovakia

RECRUITING

Clinical Site

Vranov nad Topľou, 09301, Slovakia

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

ITI Clinical Trials

CONTACT

6464409333; ITCIClinicalTrials@itci-inc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5); US (30); SE (8); SL (4); FI (4); BU (9)