Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480383
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
Sponsor:
Intra-Cellular Therapies Inc
Organization:
Intra-Cellular Therapies Inc
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Study to Assess the Efficacy Safety and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The study will be conducted in 3 periods
Screening Period up to 3 weeks during which patient eligibility will be assessed and the washout of prohibited medications will occur
Double-blind Treatment Period 6 weeks during which patients will be randomized in a 111 ratio to receive one of the 3 treatments ITI-1284 10 mg ITI-1284 20 mg or placebo
Safety Follow-up Period 1 week during which all patients will return for a safety follow-up visit
Screening Period up to 3 weeks during which patient eligibility will be assessed and the washout of prohibited medications will occur
Double-blind Treatment Period 6 weeks during which patients will be randomized in a 111 ratio to receive one of the 3 treatments ITI-1284 10 mg ITI-1284 20 mg or placebo
Safety Follow-up Period 1 week during which all patients will return for a safety follow-up visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None