Generalized Anxiety DisorderPhase 2NCT06480383
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
A Phase 2 study testing ITI-1284 10 mg and ITI-1284 20 mg in people with Generalized Anxiety Disorder, run by Intra-Cellular Therapies, Inc. at 59 sites in 6 countries.
Trial 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)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- ITI-1284 10 mg and ITI-1284 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 705 participants
- Where
- 59 sitesin 6 countries
- Study dates
- 5 Aug 2024to 21 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provide written informed consent before the initiation of any study specific procedures;
- Male or female patients ≥ 18 years of age;
- At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD (current GAD) as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:
- HAM-A Total score of ≥ 22;
- HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
- CGI-S score of ≥ 4;
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- History of inadequate response (< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire [ATRQ] for GAD) to at least 1 GAD-approved treatment (ie, one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 milligrams [mg], venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;
- Currently having an inadequate response to one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) and agrees to continue the same dosing regimen for the duration of the study.
- NOTE: The current GAD-approved treatment must be different from the GAD treatment identified as the historical failure.
Who cannot join
- Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
- Bipolar Disorder;
- MADRS total score > 18 at Screening or Baseline;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
- At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;
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- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
- At Screening or Baseline MADRS Item 10 score ≥ 5; or
- The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator.
- Lifetime history of failure to respond to > 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks).
Trial locations and contacts
59 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
59 sites in 6 countries
United States25 sites, 25 recruiting
- Recruiting
Lehigh Center for Clinical Research LLC
Allentown, Pennsylvania, 18103
- Recruiting
Michigan Clinical Research Institute
Ann Arbor, Michigan, 48105
- Recruiting
CenExeli Research LLC
Atlanta, Georgia, 30030
- Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
- Recruiting
Austin Clinical Trial Partners
Austin, Texas, 78737
- Recruiting
BioBehavioral Research of Austin PC
Austin, Texas, 78759
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
- Recruiting
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
- Recruiting
Behavioral Research Specialists LLC
Glendale, California, 91206
- Recruiting
Sun Valley Research Center
Imperial, California, 92251
- Recruiting
Synergy East
Lemon Grove, California, 91945
- Recruiting
Suburban Research Associates
Media, Pennsylvania, 19063
- Recruiting
Premier Clinical Research
Miami, Florida, 33122
- Recruiting
Global Medical Institutes
Miami, Florida, 33125
- Recruiting
Miami Dade Medical Research Institute
Miami, Florida, 33176
- Recruiting
Sunshine Medical Solution
Miami, Florida, 33186
- Recruiting
South Florida Research Inc
Miami Springs, Florida, 33166
- Recruiting
Neuro Behavioral Clinical Research
North Canton, Ohio, 44720
- Recruiting
Excell Research Inc
Oceanside, California, 92056
- Recruiting
Sooner Clinical Research
Oklahoma City, Oklahoma, 73120
- Recruiting
NRC Research Institute
Orange, California, 92868
- Recruiting
Aims Trials LLC
Plano, Texas, 75093
- Recruiting
Anderson Clinical Research
Redlands, California, 92374
- Recruiting
K2 Medical Research
Tampa, Florida, 33634
- Recruiting
Bio Behavioral Health
Toms River, New Jersey, 08755
Bulgaria13 sites, 13 recruiting
- Recruiting
Medical Center Sv Dimitar Blagoevgrad
Blagoevgrad, 2700
- Recruiting
Mental Health Center Prof. Dr. Ivan Temkov
Burgas, 8001
- Recruiting
Outpatient care-group practice for specialized psychiatric care Datamed OOD
Pleven, 5800
- Recruiting
Medical Center Mentalcare OOD
Plovdiv, 4004
- Recruiting
Mental Health Center - Rousse
Rousse, 7003
- Recruiting
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
Sofia, 1113
- Recruiting
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, 1408
- Recruiting
Medical Center Hera EOOD
Sofia, 1510
- Recruiting
Medical Center Intermedica, OOD
Sofia, 1680
- Recruiting
Medical center - VAS OOD
Targovishte, 7700
- Recruiting
Diagnostic Consulting Center Mladost - M Varna 1
Varna, 9020
- Recruiting
Diagnostic Consulting Center Mladost - M Varna
Varna, 9020
- Recruiting
Mental Health Center - Vratsa EOOD
Vratsa, 3000
Serbia7 sites, 7 recruiting
- Recruiting
Institute of Mental Health Serbia
Belgrade, 11000
- Recruiting
University Clinical Center of Serbia 1
Belgrade, 11000
- Recruiting
University Clinical Center of Serbia
Belgrade, 11000
- Recruiting
University Clinical Hospital Center Dr Dragisa Misovic- Dedi
Belgrade, 11000
- Recruiting
Special Neuropsychiatric Hospital Kovin
Kovin, 26220
- Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
- Recruiting
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
Novi Kneževac, 23330
Poland6 sites, 6 recruiting
- Recruiting
Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
Bialystok, 15-404
- Recruiting
Przychodnia Srodmiescie SP. z o.o.
Bydgoszcz, 85-080
- Recruiting
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
Gorlice, 38-300
- Recruiting
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, 64-100
- Recruiting
Filip Rybakowski Specjalistyczna Praktyka Lekarska
Poznan, 60 744
- Recruiting
Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed
Torun, 87 100
Czechia5 sites, 5 recruiting
- Recruiting
Medipa S R O
Brno, 60200
- Recruiting
A Shine S R O
Pilsen, 301 00
- Recruiting
Clintrial s r o
Prague, 10000
- Recruiting
Medical Services Prague S R O
Prague, 16000
- Recruiting
Institut Neuropsychiatricke pece
Prague, 18600
Finland3 sites, 3 recruiting
- Recruiting
Savon Psykiatripalvelu
Kuopio, 70110
- Recruiting
Oulu Mentalcare Oy
Oulu, 90100
- Recruiting
Satakunnan Psykiatripalvelu Oy at Mehilainen Oy
Tampere, 33210
About this study
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
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
- Generalized Anxiety Disorder
- Being tested
- ITI-1284 10 mg, ITI-1284 20 mg, Placebo
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-1284 10 mgDrug
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
ITI-1284 20 mgDrug
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
PlaceboDrug
Matching placebo tablet, taken once daily, sublingual administration
| Study group | Role | What they receive |
|---|---|---|
| ITI-1284 10 mg | Experimental | Not described Receives: Drug: ITI-1284 10 mg |
| ITI-1284 20 mg | Experimental | Not described Receives: Drug: ITI-1284 20 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale (HAM-A)
The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). It comprises of 14 items that are rated on a 5-point scale ranging from 0 = not present to 4 = very severe, disabling symptoms. The HAM-A total score ranges from 0 to 56 with a higher score indicating increased severity of anxiety symptoms.
Measured: Week 6
Secondary outcomes (1)
Clinical Global Impression Scale-Severity (CGI-S)
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients)
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start5 Aug 2024
- Primary completion16 Mar 2027 (estimated)
- Study completion21 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Intra-Cellular Therapies, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 705 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Intra-Cellular Therapies,Inc. Clinical Trial, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480383
- Sponsor's protocol ID
- ITI-1284-301
- Other IDs
- 2024-513302-56-00
- Status last verified
- Nov 2026
- First submitted
- 24 Jun 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06480383
- Acronym / sponsor ID
- ITI-1284-301
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 705 participants (estimated)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 16 Mar 2027 (estimated)
- Study completion
- 21 Oct 2027 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ITI-1284 10 mg | Experimental | Drug: ITI-1284 10 mg |
| ITI-1284 20 mg | Experimental | Drug: ITI-1284 20 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Provide written informed consent before the initiation of any study specific procedures;
- Male or female patients ≥ 18 years of age;
- At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD (current GAD) as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:
- History of inadequate response (< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire [ATRQ] for GAD) to at least 1 GAD-approved treatment (ie, one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 milligrams [mg], venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;
- Currently having an inadequate response to one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) and agrees to continue the same dosing regimen for the duration of the study.
Key exclusion criteria (10 listed)
- Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:
- MADRS total score > 18 at Screening or Baseline;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
- Lifetime history of failure to respond to > 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITI-1284 10 mgITI-1284 10 mg tablet, taken once daily, sublingual administration. | Drug | ITI-1284 10 mg |
| ITI-1284 20 mgITI-1284 20 mg tablet, taken once daily, sublingual administration. | Drug | ITI-1284 20 mg |
| PlaceboMatching placebo tablet, taken once daily, sublingual administration | Drug | Placebo |
Primary outcome
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Week 6
The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). It comprises of 14 items that are rated on a 5-point scale ranging from 0 = not present to 4 = very severe, disabling symptoms. The HAM-A total score ranges from 0 to 56 with a higher score indicating increased severity of anxiety symptoms.
1 secondary outcome
Clinical Global Impression Scale-Severity (CGI-S)
Time frame: Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Intra-Cellular Therapies,Inc. Clinical Trial study director
Intra-Cellular Therapies, Inc.
59 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ITI-1284 10 mg and ITI-1284 20 mg in people with Generalized Anxiety Disorder, run by Intra-Cellular Therapies, Inc. at 59 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Bulgaria, Serbia, Poland, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HAM-A) (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.