Generalized Anxiety DisorderPhase 2NCT06701903
Study of ITI-1284 as Monotherapy 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 51 sites in 5 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 570 participants
- Where
- 51 sitesin 5 countries
- Study dates
- 21 Nov 2024to 20 Jul 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent before the initiation of any study specific procedures;
- 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;
- History of inadequate response (< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire [ATRQ] for GAD) to at least 2 of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 milligram [mg], venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms.
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 (that is, at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks)
Trial locations and contacts
51 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
51 sites in 5 countries
United States25 sites, 23 recruiting
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
- Recruiting
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
- Recruiting
University of Buffalo
Buffalo, New York, 14215
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
- Recruiting
Proscience Research Group
Culver City, California, 90230
- Recruiting
Relaro Medical Trials
Dallas, Texas, 75243
- Recruiting
iResearch Atlanta LLC
Decatur, Georgia, 30030
- Recruiting
Leading Edge Research
Encino, California, 91316
- Recruiting
Wake Research PRI Encino
Encino, California, 91316
- Recruiting
University of Connecticut Health Center
Farmington, Connecticut, 06032
- Recruiting
Precise Clinical Research, Inc.
Flowood, Mississippi, 39232
- Completed
Sarkis Clinical Trials
Gainesville, Florida, 32607
- Recruiting
Woodland International Research Group
Little Rock, Arkansas, 72211
- Recruiting
CalNeuro Research
Los Angeles, California, 90025
- Recruiting
Suburban Research Associates
Media, Pennsylvania, 19063
- Recruiting
Miami Dade Medical Research Institute
Miami, Florida, 33176
- Recruiting
Sooner Clinical Research
Norman, Oklahoma, 73071
- Recruiting
Excell Research Inc
Oceanside, California, 92056
- Recruiting
Woodland Research Northwest
Rogers, Arkansas, 72758
- Recruiting
California Neuroscience Research
Sherman Oaks, California, 91403
- Recruiting
Richmond Behavioral Associates
Staten Island, New York, 10314
- Recruiting
University of South Florida
Tampa, Florida, 33613
- Completed
Pacific Clinical Research Medical Group
Upland, California, 91786
- Recruiting
Sunwise Clinical Research
Walnut Creek, California, 94596
Bulgaria9 sites, 9 recruiting
- Recruiting
Medical Center Sv Dimitar Blagoevgrad
Blagoevgrad, 2700
- Recruiting
Medical Center Lifemed
Kardzhali, 6600
- Recruiting
Medical Center Medconsult-Pleven
Pleven, 5800
- Recruiting
Medical Center Mentalcare OOD
Plovdiv, 4004
- Recruiting
Mental Health Center - Rousse
Rousse, 7003
- 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
Serbia8 sites, 8 recruiting
- Recruiting
Clinical Center Dr Dragisa Misovic Dedinje
Belgrade, 11000
- 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
Special Neuropsychiatric Hospital Kovin
Kovin, 26220
- Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
- Recruiting
University Clinical Center NIS
Niš, 18000
- Recruiting
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
Novi Kneževac, 23330
Poland5 sites, 5 recruiting
- Recruiting
Prywatne Gabinety Lekarskie PROMEDICUS
Bialystok, 15272
- Recruiting
Przychodnia Srodmiescie SP. z o.o.
Bydgoszcz, 85-080
- Recruiting
Centrum Zdrowia Alcea
Gdansk, 80 283
- Recruiting
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, 64-100
- Recruiting
Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed
Torun, 87 100
Slovakia4 sites, 4 recruiting
- Recruiting
Psychiatricka Ambulancia Mentum S.R.O.
Bratislava, 821 01
- Recruiting
Psychiatricka Ambulancia Psycholine S.R.O.
Rimavská Sobota, 979 01
- Recruiting
Centrum Zdravia R.B.K. S.R.O. Poliklinika Medic Sk
Svidník, 08901
- Recruiting
Crystal Comfort s.r.o.
Vranov nad Topľou, 093 01
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder Who Have Had Inadequate Response to Generalized Anxiety Disorder Treatment
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
- 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 10mg | Experimental | ITI-1284 10 mg tablet, taken once daily, sublingual administration. Receives: Drug: ITI-1284 10 mg |
| ITI-1284 20mg | Experimental | ITI-1284 20 mg tablet, taken once daily, sublingual administration. Receives: Drug: ITI-1284 20 mg |
| Placebo | Placebo comparator | Matching placebo tablet, taken once daily, sublingual administration 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 is comprised 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 posted22 Nov 2024
- Study start21 Nov 2024
- Primary completion14 Oct 2027 (estimated)
- Study completion20 Jul 2028 (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
- 570 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
- NCT06701903
- Sponsor's protocol ID
- ITI-1284-302
- Status last verified
- Nov 2026
- First submitted
- 20 Nov 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 Monotherapy Treatment in Patients With Generalized Anxiety Disorder Who Have Had Inadequate Response to Generalized Anxiety Disorder Treatment
- ClinicalTrials.gov ID
- NCT06701903
- Acronym / sponsor ID
- ITI-1284-302
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 14 Oct 2027 (estimated)
- Study completion
- 20 Jul 2028 (estimated)
- First posted
- 22 Nov 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 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.
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 10mg | Experimental | Drug: ITI-1284 10 mgITI-1284 10 mg tablet, taken once daily, sublingual administration. |
| ITI-1284 20mg | Experimental | Drug: ITI-1284 20 mgITI-1284 20 mg tablet, taken once daily, sublingual administration. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo tablet, taken once daily, sublingual administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide written informed consent before the initiation of any study specific procedures;
- 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 2 of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 milligram [mg], venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms.
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 (that is, at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, 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 10mg |
| ITI-1284 20 mgITI-1284 20 mg tablet, taken once daily, sublingual administration. | Drug | ITI-1284 20mg |
| 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 is comprised 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.
51 sites in 5 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 51 sites in 5 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 6 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 51 sites in United States, Bulgaria, Serbia, Poland, Slovakia. 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.