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ITI-1284 for Anxiety

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 2 GAD-approved treatments for ongoing GAD symptoms
Be older than 18 years old
Must not have
Confirmed DSM-5-TR psychiatric diagnoses of Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, other psychotic disorder, or Bipolar Disorder
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 aims to test the effectiveness, safety, and tolerance of ITI-1284 as a standalone treatment for patients with generalized anxiety disorder who have not responded well to previous treatments."

Who is the study for?
This trial is for individuals with Generalized Anxiety Disorder (GAD) who haven't found relief from other treatments. Participants must meet the DSM-5-TR criteria for GAD to join.
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's effective and safe as a solo treatment for GAD. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real medicine or placebo.
What are the potential side effects?
While specific side effects of ITI-1284 are not listed here, common ones in anxiety medication trials may include dizziness, headache, nausea, fatigue, sleep disturbances or mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've tried at least 2 treatments for anxiety that didn't work well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with a psychiatric disorder like Schizophrenia or Bipolar Disorder.
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
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
Group II: ITI-1284 10mgExperimental Treatment1 Intervention
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo tablet, taken once daily, sublingual administration

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
40 Previous Clinical Trials
10,110 Total Patients Enrolled
~380 spots leftby Jun 2027
Unbiased ResultsWe believe in providing patients with all the options.
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