Actively Recruiting
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
Led by Intra-Cellular Therapies, Inc. · Updated on 2026-01-09
570
Participants Needed
60
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.
CONDITIONS
Official Title
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Meet DSM-5-TR criteria for moderate or severe Generalized Anxiety Disorder confirmed by a structured clinical interview
- Have a Hamilton Anxiety Rating Scale (HAM-A) total score of 22 or higher
- Have HAM-A anxious mood and tension items each scored 2 or higher
- Have a Clinical Global Impressions-Severity (CGI-S) score of 4 or higher
- History of inadequate response to at least two approved GAD treatments (paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at adequate doses and duration (minimum 6 weeks)
You will not qualify if you...
- Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or other psychotic disorders
- Lifetime diagnosis of bipolar disorder
- Montgomery–Åsberg Depression Rating Scale (MADRS) total score greater than 18 at screening or baseline
- Significant risk of suicidal behavior as assessed by the investigator
- Positive suicidal ideation on C-SSRS items 4 or 5 within 6 months prior to screening or since screening at baseline
- One or more suicide attempts within 2 years prior to screening
- MADRS item 10 score of 5 or higher at screening or baseline
- Considered imminent danger to self or others by investigator assessment
- History of failure to respond to more than three approved GAD treatments at adequate doses and duration
AI-Screening
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Trial Site Locations
Total: 60 locations
1
Clinical Site
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Clinical Site
Little Rock, Arkansas, United States, 72211
Actively Recruiting
3
Clinical Site
Rogers, Arkansas, United States, 72758
Actively Recruiting
4
Clinical Site
Culver City, California, United States, 90230
Actively Recruiting
5
Clinical Site_2
Encino, California, United States, 91316
Actively Recruiting
6
Clinical Site
Encino, California, United States, 91316
Actively Recruiting
7
Clinical Site
Los Angeles, California, United States, 90025
Actively Recruiting
8
Clinical Site
Oceanside, California, United States, 92056
Actively Recruiting
9
Clinical Site
Sherman Oaks, California, United States, 91403
Actively Recruiting
10
Clinical Site
Upland, California, United States, 91786
Active, Not Recruiting
11
Clinical Site
Walnut Creek, California, United States, 94596
Actively Recruiting
12
Clinical Site
Farmington, Connecticut, United States, 06030
Actively Recruiting
13
Clinical Site
Gainesville, Florida, United States, 32607
Active, Not Recruiting
14
Clinical Site
Miami, Florida, United States, 33176
Actively Recruiting
15
Cinical Site
Orlando, Florida, United States, 32803
Active, Not Recruiting
16
Clinical Site
Tampa, Florida, United States, 33612
Not Yet Recruiting
17
Clinical Site
Tampa, Florida, United States, 33613
Not Yet Recruiting
18
Clinical Site
Decatur, Georgia, United States, 30030
Actively Recruiting
19
Clinical Site
Chicago, Illinois, United States, 60611
Not Yet Recruiting
20
Clinical Site
Boston, Massachusetts, United States, 02131
Active, Not Recruiting
21
Clinical Site
Flowood, Mississippi, United States, 39232
Actively Recruiting
22
Clinical Site
Brooklyn, New York, United States, 11235
Actively Recruiting
23
Clinical Site
Buffalo, New York, United States, 14215
Active, Not Recruiting
24
Clinical Site
Staten Island, New York, United States, 10314
Actively Recruiting
25
Clinical Site
Columbus, Ohio, United States, 43210
Not Yet Recruiting
26
Clinical Site
Oklahoma City, Oklahoma, United States, 73116
Actively Recruiting
27
Clinical Site
Media, Pennsylvania, United States, 19063
Actively Recruiting
28
Clinical Site
Dallas, Texas, United States, 75231
Not Yet Recruiting
29
Clinical Site
Dallas, Texas, United States, 75243
Actively Recruiting
30
Clinical Site
Bellevue, Washington, United States, 98007
Actively Recruiting
31
Clinical Site
Blagoevgrad, Bulgaria, 2700
Actively Recruiting
32
Clinical Site
Kardzhali, Bulgaria, 6600
Actively Recruiting
33
Clinical Site
Pleven, Bulgaria, 5800
Actively Recruiting
34
Clinical Site
Plovdiv, Bulgaria, 4004
Actively Recruiting
35
Clinical Site
Rousse, Bulgaria, 7003
Actively Recruiting
36
Clinical Site
Sofia, Bulgaria, 1408
Actively Recruiting
37
Clinical Site
Sofia, Bulgaria, 1510
Actively Recruiting
38
Clinical Site
Sofia, Bulgaria, 1680
Actively Recruiting
39
Clinical Site
Targovishte, Bulgaria, 7700
Actively Recruiting
40
Clinical Site
Helsinki, Finland, 00100
Not Yet Recruiting
41
Clinical Site
Kuopio, Finland, 70110
Not Yet Recruiting
42
Clinical Site
Oulu, Finland, 90100
Not Yet Recruiting
43
Clinical Site
Tampere, Finland, 33210
Not Yet Recruiting
44
Clinical Site
Bialystok, Poland, 15272
Actively Recruiting
45
Clinical Site
Bydgoszcz, Poland, 85-080
Actively Recruiting
46
Clinical Site
Gdansk, Poland, 80283
Actively Recruiting
47
Clinical Site
Leszno, Poland, 64100
Actively Recruiting
48
Clinical Site
Torun, Poland, 87100
Actively Recruiting
49
Clinical Site_2
Belgrade, Serbia, 11000
Actively Recruiting
50
Clinical Site_3
Belgrade, Serbia, 11000
Actively Recruiting
51
Clinical Site_4
Belgrade, Serbia, 11000
Actively Recruiting
52
Clinical Site
Belgrade, Serbia, 11000
Actively Recruiting
53
Clinical Site
Kovin, Serbia, 26220
Actively Recruiting
54
Clinical Site
Kragujevac, Serbia, 34000
Actively Recruiting
55
Clinical Site
Niš, Serbia, 18000
Actively Recruiting
56
Clinical Site
Novi Kneževac, Serbia, 23330
Actively Recruiting
57
Clinical Site
Bratislava, Slovakia, 82101
Actively Recruiting
58
Clinical Site
Rimavská Sobota, Slovakia, 97901
Actively Recruiting
59
Clinical Site
Svidník, Slovakia, 08901
Actively Recruiting
60
Clinical Site
Vranov nad Topľou, Slovakia, 09301
Actively Recruiting
Research Team
I
ITI Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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