Home › Trials › NCT06701903

Treatment for Generalized Anxiety Disorder with ITI-1284

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

PHASE2 · Intra-Cellular Therapies, Inc. · NCT06701903

This study is testing whether a new medication called ITI-1284 can help people with Generalized Anxiety Disorder who haven't found relief from other treatments.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment570 (estimated)
Ages18 Years and up
SexAll
SponsorIntra-Cellular Therapies, Inc. (industry)
Locations60 sites (Birmingham, Alabama and 59 other locations)
Trial IDNCT06701903 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study evaluates the efficacy, safety, and tolerability of ITI-1284 as a monotherapy for patients diagnosed with Generalized Anxiety Disorder (GAD) who have not adequately responded to previous treatments. The study consists of a screening period, a 6-week double-blind treatment phase where participants receive either ITI-1284 or a placebo, and a safety follow-up period. Approximately 570 patients will be enrolled and randomized to receive either 10 mg or 20 mg of ITI-1284 or a placebo. The study aims to provide insights into the potential benefits of ITI-1284 for managing GAD symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with moderate to severe Generalized Anxiety Disorder who have had an inadequate response to at least two approved GAD treatments.

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

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from Generalized Anxiety Disorder who have not responded to existing therapies.

How similar studies have performed: While this approach is being tested in this specific context, similar studies exploring new treatments for GAD have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Where this trial is running

Birmingham, Alabama and 59 other locations

+10 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 →

Conditions: Generalized Anxiety Disorder

Last reviewed 2026-05-15 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.