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

NCT06480383 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ITI-1284-301
• Study Type: interventional
• Target: 705
• Locations: 6 countries
• Sites: 69

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD 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 comprises of 14 items that are rated on a 5-point scale ranging from 0 = not present to 4 = very severe, disabling symptoms. The HAM-A total score ranges from 0 to 56 with a higher score indicating increased severity of anxiety symptoms.

  Week 6

Secondary Outcomes (1)

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

  Week 6

Study Arms (3)

ITI-1284 10mg

EXPERIMENTAL

Drug: ITI-1284 10 mg

ITI-1284 20mg

EXPERIMENTAL

Drug: ITI-1284 20 mg

Placebo

PLACEBO COMPARATOR

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;
• Male or female patients ≥ 18 years of age;
• 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 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;
• 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.

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 (69)

Clinical Site

Chandler, Arizona, 85224, United States

ACTIVE NOT RECRUITING

Clinical Site

Encino, California, 91316, United States

RECRUITING

Clinical Site

Glendale, California, 91206, United States

RECRUITING

Clinical Site

Imperial, California, 92251, United States

RECRUITING

Clinical Site

Lemon Grove, California, 91945, United States

RECRUITING

Clinical Site

Oceanside, California, 92056, United States

RECRUITING

Clinical Site

Orange, California, 92868, United States

RECRUITING

Clinical Site

Redlands, California, 92374, United States

RECRUITING

Clinical Site

San Diego, California, 92106, United States

ACTIVE NOT RECRUITING

Clinical Site

Farmington, Connecticut, 06030, United States

RECRUITING

Clinical Site

Gainesville, Florida, 32607, United States

WITHDRAWN

Clinical Site

Lauderhill, Florida, 33319, United States

RECRUITING

Clinical Site

Maitland, Florida, 32751, United States

RECRUITING

Clinical Site

Miami, Florida, 33122, United States

RECRUITING

Clinical Site

Miami, Florida, 33125, United States

RECRUITING

Clinical Site

Miami, Florida, 33176, United States

RECRUITING

Clinical Site

Miami Springs, Florida, 33166, United States

RECRUITING

Clinical Site

Orlando, Florida, 32803, United States

ACTIVE NOT RECRUITING

Clinical Site

Tampa, Florida, 33634, United States

RECRUITING

Clinical Site

Atlanta, Georgia, 30331, United States

RECRUITING

Clinical Site

Decatur, Georgia, 30030, United States

RECRUITING

Clinical Site

Boston, Massachusetts, 02131, United States

ACTIVE NOT RECRUITING

Clinical Site

Ann Arbor, Michigan, 48105, United States

RECRUITING

Clinical Site

Toms River, New Jersey, 08755, United States

RECRUITING

Clinical Site

Brooklyn, New York, 11235, United States

RECRUITING

Clinical Site

North Canton, Ohio, 44720, United States

RECRUITING

Clinical Site

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Clinical Site

Allentown, Pennsylvania, 18104, United States

RECRUITING

Clinical Site

Media, Pennsylvania, 19063, United States

RECRUITING

Clinical Site

Austin, Texas, 78737, United States

RECRUITING

Clinical Site

Austin, Texas, 78759, United States

RECRUITING

Clinical SIte

DeSoto, Texas, 75115, United States

ACTIVE NOT RECRUITING

Clinical Site

Plano, Texas, 75093, United States

RECRUITING

Clinical Site

Bellevue, Washington, 98007, United States

RECRUITING

Clinical Site

Blagoevgrad, 2700, Bulgaria

RECRUITING

Clinical Site

Burgas, 8001, Bulgaria

RECRUITING

Clinical Site

Pleven, 5800, Bulgaria

RECRUITING

Clinical Site

Plovdiv, 4002, Bulgaria

RECRUITING

Clinical Site

Rousse, 7000, Bulgaria

RECRUITING

Clinical Site

Sofia, 1113, Bulgaria

RECRUITING

Clinical Site

Sofia, 1408, Bulgaria

RECRUITING

Clinical Site

Sofia, 1510, Bulgaria

RECRUITING

Clinical Site

Sofia, 1680, Bulgaria

RECRUITING

Clinical Site

Targovishte, 7703, Bulgaria

RECRUITING

Clinical Site

Varna, 9010, Bulgaria

RECRUITING

Clinical Site

Varna, 9020, Bulgaria

RECRUITING

Clinical Site

Vratsa, 3000, Bulgaria

RECRUITING

Clinical Site

Brno, 602 00, Czechia

RECRUITING

Clinical Site

Pilsen, 301 00, Czechia

RECRUITING

Clinical Site

Prague, 100 00, Czechia

RECRUITING

Clinical Site

Prague, 160 00, Czechia

RECRUITING

Clinical Site

Prague, 186 00, Czechia

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, 15404, Poland

RECRUITING

Clinical Site

Bydgoszcz, 85-080, Poland

RECRUITING

Clinical Site

Gorlice, 38300, Poland

RECRUITING

Clinical Site

Leszno, 64100, Poland

RECRUITING

Clinical Site

Poznan, 60744, Poland

NOT YET 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

Novi Kneževac, 23330, Serbia

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: June 24, 2024
• First Posted: June 28, 2024
• Study Start: August 5, 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 (6); SE (7); BU (13); CZ (5); US (34); FI (4)