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Evaluating ITI-1284 for treating Generalized Anxiety Disorder

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment

Phase 2 Interventional Intra-Cellular Therapies, Inc. · NCT06480383

This study is testing a new medication called ITI-1284 to see if it can help people with Generalized Anxiety Disorder who haven't found relief from their current treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment705 (estimated)
Ages18 Years and up
SexAll
SponsorIntra-Cellular Therapies, Inc. Industry-sponsored
Locations69 sites (Chandler, Arizona and 68 other locations)
Trial IDNCT06480383 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 as an adjunctive treatment for patients with Generalized Anxiety Disorder (GAD) who have not adequately responded to existing therapies. The study consists of a screening period, a 6-week double-blind treatment phase where participants receive either ITI-1284 or placebo, and a 1-week safety follow-up. Participants will be evaluated based on specific diagnostic criteria and anxiety symptom scales to determine eligibility and treatment response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe GAD who have shown inadequate response to at least one approved GAD treatment.

Not a fit: Patients who have not been diagnosed with GAD or those who have not tried any GAD-approved treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with GAD who have not responded well to current therapies.

How similar studies have performed: Other studies have explored adjunctive treatments for GAD, but the specific approach with ITI-1284 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Provide written informed consent before the initiation of any study specific procedures;
2. Male or female patients ≥ 18 years of age;
3. 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:

   1. HAM-A Total score of ≥ 22;
   2. HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
   3. CGI-S score of ≥ 4;
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;
5. 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.

Exclusion Criteria:

1. Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:

   1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
   2. Bipolar Disorder;
2. MADRS total score \> 18 at Screening or Baseline;
3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or

   1. 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;
   2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
   3. At Screening or Baseline MADRS Item 10 score ≥ 5; or
   4. The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator.
4. 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).

Where this trial is running

Chandler, Arizona and 68 other locations

+19 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Generalized Anxiety Disorder
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.