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

NCT06701903

RecruitingPhase 2

Sponsor: Intra-Cellular Therapies, Inc.

Conditions: Generalized Anxiety Disorder

Interventions: ITI-1284 10 mg, ITI-1284 20 mg, Placebo

Countries: United States, Bulgaria, Poland, Serbia, Slovakia

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 (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)
Locations (51)
  • Birmingham, Alabama, United States
  • Little Rock, Arkansas, United States
  • Rogers, Arkansas, United States
  • Culver City, California, United States
  • Encino, California, United States
  • Encino, California, United States
  • Los Angeles, California, United States
  • Oceanside, California, United States
  • Sherman Oaks, California, United States
  • Upland, California, United States
  • Walnut Creek, California, United States
  • Farmington, Connecticut, United States
  • Gainesville, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Decatur, Georgia, United States
  • Flowood, Mississippi, United States
  • Brooklyn, New York, United States
  • Buffalo, New York, United States
  • Staten Island, New York, United States
  • Columbus, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Media, Pennsylvania, United States
  • Dallas, Texas, United States
  • Bellevue, Washington, United States
  • Blagoevgrad, Bulgaria
  • Kardzhali, Bulgaria
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Rousse, Bulgaria
  • + 21 more on CT.gov