RecruitingGeneralized Anxiety Disorder

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

Eligible age

All ages

Accepts

All genders

Locations

11 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

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 (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.

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