Evaluating ITI-1284 for treating Generalized Anxiety Disorder

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 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.

Why it matters

Who can join: the full rules

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 (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:

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

Where it's running

• Behavioral Research Specialists LLC
  Glendale, California, United States Recruiting
• Sun Valley Research Center
  Imperial, California, United States Recruiting
• Synergy East
  Lemon Grove, California, United States Recruiting
• Excell Research Inc
  Oceanside, California, United States Recruiting
• NRC Research Institute
  Orange, California, United States Recruiting
• Anderson Clinical Research
  Redlands, California, United States Recruiting

+9 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

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

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• 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.

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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.