Treatment for Generalized Anxiety Disorder with ITI-1284

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 (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 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 (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)

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Woodland International Research Group
  Little Rock, Arkansas, United States Recruiting
• Woodland Research Northwest
  Rogers, Arkansas, United States Recruiting
• Proscience Research Group
  Culver City, California, United States Recruiting
• Leading Edge Research
  Encino, California, United States Recruiting
• Wake Research PRI Encino
  Encino, California, United States Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adjunctive JNJ-99245354 for Generalized Anxiety Disorder (GAD)

  This study tests whether adding JNJ-99245354 to existing GAD treatment helps reduce anxiety more than a placebo for adults with GAD who didn’t get adequate benefit from previous treatments.

  Recruiting at 4 sites Phase 3 Intra-Cellular Therapies, Inc. · Temecula, California and 3 other locations · NCT07856420

• Testing ITI-1284 for Generalized Anxiety Disorder (GAD)

  This phase 3 trial tests whether ITI-1284 is safe and tolerable when taken alone or with other medicines by adults with generalized anxiety disorder who haven’t responded to prior treatment.

  Recruiting at 3 sites Phase 3 Intra-Cellular Therapies, Inc. · Los Angeles, California and 2 other locations · NCT07807865

• Long-term safety and tolerability of SEP-363856 in adults with generalized anxiety disorder

  In adults with generalized anxiety disorder, this Phase 3 open-label extension tests whether continuing SEP-363856 at 50 mg or 75 mg daily for 26 weeks is safe, tolerable, and possibly helpful.

  Recruiting at 2 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Jacksonville, Florida and 1 other locations · NCT07786454

• Anxiety Skills Study: See if video skill training plus therapy helps people with anxiety

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  Recruiting Ohio State University · Columbus, Ohio · NCT07774481

• Continuous Theta Burst Stimulation for Generalized Anxiety Disorder (cTBS for GAD)

  This study tests whether applying continuous theta burst stimulation to the right posterior parietal cortex or the right dorsolateral prefrontal cortex helps adults with generalized anxiety disorder.

  Recruiting Military Hospital 175 · Ho Chi Minh City · NCT07770919

• Fixed-dose SEP-363856 vs placebo for adults with generalized anxiety disorder

  This trial tests whether a fixed 75 mg/day dose of SEP-363856 helps adults with generalized anxiety disorder more than placebo over 8 weeks.

  Recruiting at 11 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Redlands, California and 10 other locations · NCT07767903

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.