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ITI-1284 for Generalized Anxiety Disorder

Phase 2
Recruiting
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of inadequate response to at least 1 GAD-approved treatment
Be older than 18 years old
Must not have
Lifetime history of failure to respond to > 3 of the approved treatments for GAD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6

Summary

This trial is looking at whether a new drug called ITI-1284 is effective and safe when used alongside standard treatment for Generalized Anxiety Disorder in patients who are not responding well to their current treatment

Who is the study for?
This trial is for individuals with Generalized Anxiety Disorder (GAD) who haven't had enough relief from their current treatment. Participants must meet the criteria for GAD as defined by a manual called DSM-5-TR.
What is being tested?
The study tests ITI-1284 at two different doses (10 mg and 20 mg) against a placebo, to see if it can better help manage anxiety when added to existing treatments. It's conducted across multiple centers where patients are randomly assigned to one of the options in a blinded manner.
What are the potential side effects?
Potential side effects of ITI-1284 aren't specified here, but common ones for anxiety medications may include drowsiness, dizziness, nausea, and headache. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have tried at least one approved treatment without success.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have tried more than 3 treatments for anxiety without success.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hamilton Anxiety Rating Scale (HAM-A)
Secondary study objectives
Clinical Global Impression Scale-Severity (CGI-S)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: ITI-1284 20mgExperimental Treatment1 Intervention
Group II: ITI-1284 10mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

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Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
38 Previous Clinical Trials
9,221 Total Patients Enrolled
~470 spots leftby Dec 2026
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