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Study of ITI-1284 for Generalized Anxiety Disorder

This study is looking into ITI-1284 as a possible treatment for Generalized Anxiety Disorder (GAD). You might be able to join if you are an adult (18 years or older) with moderate or severe GAD, and your current treatments haven't fully helped. The study will test two different doses of ITI-1284 (10 mg and 20 mg) against a placebo (an inactive pill that looks the same). All participants will take a tablet once a day under their tongue. Researchers will measure how well ITI-1284 works by looking at changes in your anxiety symptoms using a scale called the Hamilton Anxiety Rating Scale (HAM-A) after 6 weeks. The study aims to enroll about 570 participants.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive ITI-1284 or placebo, and neither you nor your doctor will know which you are receiving. Approximately 570 participants will be involved.
What's involved
You would go through a screening period of up to 2 weeks, followed by 6 weeks of taking the study medication daily, and then a 1-week safety follow-up visit.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a safety follow-up visit approximately 1 week after their last dose of study medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06701903

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Intra-Cellular Therapies, Inc.
~570 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:ITI-1284 10 mgITI-1284 20 mgPlacebo

At a glance

Recruiting sites
49 of 51 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hamilton Anxiety Rating Scale (HAM-A)
Measured over Week 6

Conditions

Generalized Anxiety Disorder

Explore related trials

Generalized Anxiety Disorder

Where it's being run

51 sites across 17 states
Bulgaria9
California8
Serbia8
Poland5
Slovakia4
Florida3
New York3
Arkansas2

Study leadership

  • Intra-Cellular Therapies,Inc. Clinical Trial · STUDY_DIRECTOR · Intra-Cellular Therapies, Inc.

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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 (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), 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 (that is, at least a minimum total daily dose of paroxetine 20 milligram \[mg\], venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms.

Exclusion

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 (that is, at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks)

What this trial measures

  • 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 = 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.