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ITI-1284 for Anxiety

Oceanside, CA
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
Have you tried at least 2 of the following medications and experienced a poor response? Paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone.
Be older than 18 years old
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."

See full description
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.Check my eligibility
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.See study design
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
Select...
Have you tried at least 2 of the following medications and experienced a poor response? Paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone.

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

Closest Location:Clinical Site· Oceanside, CA· 1953 miles

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
41 Previous Clinical Trials
10,176 Total Patients Enrolled
~380 spots leftby Jun 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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