Actively Recruiting
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
Led by Intra-Cellular Therapies, Inc. · Updated on 2026-01-09
705
Participants Needed
69
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of ITI-1284 as an Adjunctive 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
- Be male or female aged 18 years or older
- 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 scores of 2 or higher on items 1 (anxious mood) and 2 (tension)
- Have a Clinical Global Impression - Severity (CGI-S) score of 4 or higher
- Have a history of inadequate response (less than 50% improvement) to at least one approved GAD treatment taken at the minimum dose and for at least 6 weeks
- Currently have an inadequate response to one approved GAD treatment taken at an adequate dose for at least 6 weeks prior to screening and agree to continue this treatment during the study
- The current GAD treatment must be different from the one identified as the historical failure
You will not qualify if you...
- Have a lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or other psychotic disorder
- Have a lifetime diagnosis of bipolar disorder
- Have a Montgomery-Åsberg Depression Rating Scale (MADRS) total score greater than 18 at screening or baseline
- Be considered at significant risk for suicidal behavior as assessed by the investigator
- Have scored "yes" on suicidal ideation items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to screening or since the screening visit
- Have had one or more suicidal attempts within 2 years prior to screening
- Have a MADRS item 10 score of 5 or higher at screening or baseline
- Be considered an imminent danger to self or others by the investigator
- Have failed to respond to more than 3 approved GAD treatments at adequate doses and durations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 69 locations
1
Clinical Site
Chandler, Arizona, United States, 85224
Active, Not Recruiting
2
Clinical Site
Encino, California, United States, 91316
Actively Recruiting
3
Clinical Site
Glendale, California, United States, 91206
Actively Recruiting
4
Clinical Site
Imperial, California, United States, 92251
Actively Recruiting
5
Clinical Site
Lemon Grove, California, United States, 91945
Actively Recruiting
6
Clinical Site
Oceanside, California, United States, 92056
Actively Recruiting
7
Clinical Site
Orange, California, United States, 92868
Actively Recruiting
8
Clinical Site
Redlands, California, United States, 92374
Actively Recruiting
9
Clinical Site
San Diego, California, United States, 92106
Active, Not Recruiting
10
Clinical Site
Farmington, Connecticut, United States, 06030
Actively Recruiting
11
Clinical Site
Gainesville, Florida, United States, 32607
Withdrawn
12
Clinical Site
Lauderhill, Florida, United States, 33319
Actively Recruiting
13
Clinical Site
Maitland, Florida, United States, 32751
Actively Recruiting
14
Clinical Site
Miami, Florida, United States, 33122
Actively Recruiting
15
Clinical Site
Miami, Florida, United States, 33125
Actively Recruiting
16
Clinical Site
Miami, Florida, United States, 33176
Actively Recruiting
17
Clinical Site
Miami Springs, Florida, United States, 33166
Actively Recruiting
18
Clinical Site
Orlando, Florida, United States, 32803
Active, Not Recruiting
19
Clinical Site
Tampa, Florida, United States, 33634
Actively Recruiting
20
Clinical Site
Atlanta, Georgia, United States, 30331
Actively Recruiting
21
Clinical Site
Decatur, Georgia, United States, 30030
Actively Recruiting
22
Clinical Site
Boston, Massachusetts, United States, 02131
Active, Not Recruiting
23
Clinical Site
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
24
Clinical Site
Toms River, New Jersey, United States, 08755
Actively Recruiting
25
Clinical Site
Brooklyn, New York, United States, 11235
Actively Recruiting
26
Clinical Site
North Canton, Ohio, United States, 44720
Actively Recruiting
27
Clinical Site
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
28
Clinical Site
Allentown, Pennsylvania, United States, 18104
Actively Recruiting
29
Clinical Site
Media, Pennsylvania, United States, 19063
Actively Recruiting
30
Clinical Site
Austin, Texas, United States, 78737
Actively Recruiting
31
Clinical Site
Austin, Texas, United States, 78759
Actively Recruiting
32
Clinical SIte
DeSoto, Texas, United States, 75115
Active, Not Recruiting
33
Clinical Site
Plano, Texas, United States, 75093
Actively Recruiting
34
Clinical Site
Bellevue, Washington, United States, 98007
Actively Recruiting
35
Clinical Site
Blagoevgrad, Bulgaria, 2700
Actively Recruiting
36
Clinical Site
Burgas, Bulgaria, 8001
Actively Recruiting
37
Clinical Site
Pleven, Bulgaria, 5800
Actively Recruiting
38
Clinical Site
Plovdiv, Bulgaria, 4002
Actively Recruiting
39
Clinical Site
Rousse, Bulgaria, 7000
Actively Recruiting
40
Clinical Site
Sofia, Bulgaria, 1113
Actively Recruiting
41
Clinical Site
Sofia, Bulgaria, 1408
Actively Recruiting
42
Clinical Site
Sofia, Bulgaria, 1510
Actively Recruiting
43
Clinical Site
Sofia, Bulgaria, 1680
Actively Recruiting
44
Clinical Site
Targovishte, Bulgaria, 7703
Actively Recruiting
45
Clinical Site
Varna, Bulgaria, 9010
Actively Recruiting
46
Clinical Site
Varna, Bulgaria, 9020
Actively Recruiting
47
Clinical Site
Vratsa, Bulgaria, 3000
Actively Recruiting
48
Clinical Site
Brno, Czechia, 602 00
Actively Recruiting
49
Clinical Site
Pilsen, Czechia, 301 00
Actively Recruiting
50
Clinical Site
Prague, Czechia, 100 00
Actively Recruiting
51
Clinical Site
Prague, Czechia, 160 00
Actively Recruiting
52
Clinical Site
Prague, Czechia, 186 00
Actively Recruiting
53
Clinical Site
Helsinki, Finland, 00100
Not Yet Recruiting
54
Clinical Site
Kuopio, Finland, 70110
Not Yet Recruiting
55
Clinical Site
Oulu, Finland, 90100
Not Yet Recruiting
56
Clinical Site
Tampere, Finland, 33210
Not Yet Recruiting
57
Clinical Site
Bialystok, Poland, 15404
Actively Recruiting
58
Clinical Site
Bydgoszcz, Poland, 85-080
Actively Recruiting
59
Clinical Site
Gorlice, Poland, 38300
Actively Recruiting
60
Clinical Site
Leszno, Poland, 64100
Actively Recruiting
61
Clinical Site
Poznan, Poland, 60744
Not Yet Recruiting
62
Clinical Site
Torun, Poland, 87100
Actively Recruiting
63
Clinical Site 2
Belgrade, Serbia, 11000
Actively Recruiting
64
Clinical Site 3
Belgrade, Serbia, 11000
Actively Recruiting
65
Clinical Site 4
Belgrade, Serbia, 11000
Actively Recruiting
66
Clinical Site
Belgrade, Serbia, 11000
Actively Recruiting
67
Clinical Site
Kovin, Serbia, 26220
Actively Recruiting
68
Clinical Site
Kragujevac, Serbia, 34000
Actively Recruiting
69
Clinical Site
Novi Kneževac, Serbia, 23330
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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