RecruitingGeneralized Anxiety Disorder

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

Eligible age

18+ yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

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About this study

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.

Sponsor: Intra-Cellular Therapies, Inc.

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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