A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)

NCT07807865 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: ITI-1284-3052026-527316-16-00
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  Up to Week 52

Secondary Outcomes (2)

• Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score

  Baseline up to Week 52

• Change from Baseline in Clinical Global Impression-Severity (CGI S) Score

  Baseline up to Week 52

Study Arms (1)

ITI-1284

EXPERIMENTAL

Participants from acute ITI-1284 GAD studies (Study ITI-1284-301 \[NCT06480383\] and Study ITI-1284-302 \[NCT06701903\]) ("roll-over participants") who meet all eligibility criteria will directly enter this study at the completion of Week 6 of the double-blind treatment period of the lead-in studies (Study ITI-1284-301 and Study ITI-1284-302). Roll-over participants will continue with their assigned monotherapy treatment of ITI-1284 or GAD-approved treatment along with ITI-1284 from the lead-in studies during this open label study. De novo participants who meet all eligibility criteria will either receive ITI-1284 monotherapy or ITI-1284 along with GAD approved treatment for up to 52 weeks.

Drug: ITI-1284

Interventions

ITI-1284 DRUG

ITI-1284 will be administered sublingually.

ITI-1284

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
• Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study
• Male or female of childbearing potential and agrees to use a highly effective method of birth control from the time informed consent is provided until 30 days after the last dose of ITI-1284 for females and 90 days after the last dose of ITI-1284 for males
• Ability to follow study instructions and likely to complete all required visits
• In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302)
• If entering from lead-in study ITI-1284-301, must be expected to continue their ongoing anti-depressant therapy (ADT) or buspirone from the lead-in study
• Provide written informed consent before the initiation of any study-specific procedures
• Male or female participants greater than or equal to (\>=) 18 years of age
• Has a body mass index (BMI) of 19-40 kilogram per meter squared (kg/m\^2), inclusive
• At screening, meet diagnostic and statistical manual of mental disorders, fifth edition, text revision (DSM-5-TR) diagnostic criteria for moderate or severe generalized anxiety disorder (GAD) (current GAD) as confirmed by the investigator or sponsor-approved rater using the structured clinical interview for DSM-5, clinical trials version (SCID 5-CT)
• Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study

You may not qualify if:

• In the opinion of the Investigator, the participant has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or: a. At baseline, the participant scores "yes" on suicidal Ideation Items 4 or 5 of the Columbia-suicide severity rating scale (C-SSRS) "Since Last Visit" version; b. At baseline, the participant scores \>= 5 on the Montgomery-Asberg depression rating scale (MADRS) Item 10 (suicidal Thoughts); c. The participant is considered to be an imminent danger to themself or others based on the assessment of the Investigator
• The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline
• Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study
• The participant has any other condition that may be detrimental to the participant if they participate in the study
• In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study
• Within the participant's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder
• Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders; b. moderate or severe alcohol or substance use disorders; c. moderate or severe major depressive disorder (MDD)
• MADRS total score greater than (\>) 18 at screening or baseline
• The participant has received electroconvulsive therapy (ECT) or vagal nerve stimulation within the past 5 years, or repetitive trans cranial magnetic stimulation within the last 2 years, or had a failure in response to ECT at any time
• The participant has known hypersensitivity or intolerance to ITI-007 (lumateperone), ITI-1284, or to any of the excipients

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (3)

CalNeuro Research

Los Angeles, California, 90025, United States

RECRUITING

Sunshine Medical Research Studies Inc

Miami, Florida, 33186, United States

RECRUITING

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Intra-Cellular Therapies, Inc. Clinical Trial

  Intra-Cellular Therapies, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: September 3, 2026
• Primary Completion (Estimated): February 18, 2030
• Study Completion (Estimated): March 4, 2030
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (3)