Generalized Anxiety DisorderPhase 3NCT07807865
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
A Phase 3 study testing ITI-1284 in people with Generalized Anxiety Disorder, run by Intra-Cellular Therapies, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Sep 2026to 4 Mar 2030
- Phase
- Phase 3
- 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
- Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study
- Male or female of childbearing potential and agrees to use a highly effective method of birth control from the time informed consent is provided until 30 days after the last dose of ITI-1284 for females and 90 days after the last dose of ITI-1284 for males
- Ability to follow study instructions and likely to complete all required visits
- In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302)
- If entering from lead-in study ITI-1284-301, must be expected to continue their ongoing anti-depressant therapy (ADT) or buspirone from the lead-in study
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- Provide written informed consent before the initiation of any study-specific procedures
- Male or female participants greater than or equal to (>=) 18 years of age
- Has a body mass index (BMI) of 19-40 kilogram per meter squared (kg/m^2), inclusive
- At screening, meet diagnostic and statistical manual of mental disorders, fifth edition, text revision (DSM-5-TR) diagnostic criteria for moderate or severe generalized anxiety disorder (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)
- Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study
Who cannot join
- In the opinion of the Investigator, the participant has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or: a. At baseline, the participant scores "yes" on suicidal Ideation Items 4 or 5 of the Columbia-suicide severity rating scale (C-SSRS) "Since Last Visit" version; b. At baseline, the participant scores >= 5 on the Montgomery-Asberg depression rating scale (MADRS) Item 10 (suicidal Thoughts); c. The participant is considered to be an imminent danger to themself or others based on the assessment of the Investigator
- The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline
- Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study
- The participant has any other condition that may be detrimental to the participant if they participate in the study
- In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study
- Within the participant's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder
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- Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders; b. moderate or severe alcohol or substance use disorders; c. moderate or severe major depressive disorder (MDD)
- MADRS total score greater than (>) 18 at screening or baseline
- The participant has received electroconvulsive therapy (ECT) or vagal nerve stimulation within the past 5 years, or repetitive trans cranial magnetic stimulation within the last 2 years, or had a failure in response to ECT at any time
- The participant has known hypersensitivity or intolerance to ITI-007 (lumateperone), ITI-1284, or to any of the excipients
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
- Recruiting
CalNeuro Research
Los Angeles, California, 90025
- Recruiting
Sunshine Medical Research Studies Inc
Miami, Florida, 33186
About this study
Official title: An Open-label, Multicenter Trial to Assess the Long-term Safety and Tolerability of ITI 1284 as Either Adjunctive or Monotherapy Treatment in Patients With Generalized Anxiety Disorder (GAD) With a History of Inadequate Response to GAD Treatment
The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- ITI-1284
- 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-1284Drug
ITI-1284 will be administered sublingually.
| Study group | Role | What they receive |
|---|---|---|
| ITI-1284 | Experimental | Participants from acute ITI-1284 GAD studies (Study ITI-1284-301 [NCT06480383] and Study ITI-1284-302 [NCT06701903]) ("roll-over participants") who meet all eligibility criteria will directly enter this study at the completion of Week 6 of the double-blind treatment period of the lead-in studies (Study ITI-1284-301 and Study ITI-1284-302). Roll-over participants will continue with their assigned monotherapy treatment of ITI-1284 or GAD-approved treatment along with ITI-1284 from the lead-in studies during this open label study. De novo participants who meet all eligibility criteria will either receive ITI-1284 monotherapy or ITI-1284 along with GAD approved treatment for up to 52 weeks. Receives: Drug: ITI-1284 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to Week 52
Secondary outcomes (2)
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
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). Each item is 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 where higher score indicates greater severity in symptoms.
Measured: Baseline up to Week 52
Change from Baseline in Clinical Global Impression-Severity (CGI S) Score
The CGI-S scale is a standardized assessment tool that the clinician can use to rate the overall severity of illness. The CGI-S asks the clinician: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on the following seven-point scale: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. Higher scores indicate worse outcome.
Measured: Baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start3 Sep 2026
- Primary completion18 Feb 2030 (estimated)
- Study completion4 Mar 2030 (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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 900 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
- NCT07807865
- Sponsor's protocol ID
- ITI-1284-305
- Other IDs
- 2026-527316-16-00
- Status last verified
- Nov 2026
- First submitted
- 2 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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
- An Open-label, Multicenter Trial to Assess the Long-term Safety and Tolerability of ITI 1284 as Either Adjunctive or Monotherapy Treatment in Patients With Generalized Anxiety Disorder (GAD) With a History of Inadequate Response to GAD Treatment
- ClinicalTrials.gov ID
- NCT07807865
- Acronym / sponsor ID
- ITI-1284-305
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 18 Feb 2030 (estimated)
- Study completion
- 4 Mar 2030 (estimated)
- First posted
- 8 Sep 2026 (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.
The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ITI-1284 | Experimental | Drug: ITI-1284Participants from acute ITI-1284 GAD studies (Study ITI-1284-301 [NCT06480383] and Study ITI-1284-302 [NCT06701903]) ("roll-over participants") who meet all eligibility criteria will directly enter this study at the completion of Week 6 of the double-blind treatment period of the lead-in studies (Study ITI-1284-301 and Study ITI-1284-302). Roll-over participants will continue with their assigned monotherapy treatment of ITI-1284 or GAD-approved treatment along with ITI-1284 from the lead-in studies during this open label study. De novo participants who meet all eligibility criteria will either receive ITI-1284 monotherapy or ITI-1284 along with GAD approved treatment for up to 52 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide written informed consent before the initiation of any study specific procedures
- Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study
- Male or female of childbearing potential and agrees to use a highly effective method of birth control from the time informed consent is provided until 30 days after the last dose of ITI-1284 for females and 90 days after the last dose of ITI-1284 for males
- Ability to follow study instructions and likely to complete all required visits
- In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302)
Key exclusion criteria (10 listed)
- In the opinion of the Investigator, the participant has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or: a. At baseline, the participant scores "yes" on suicidal Ideation Items 4 or 5 of the Columbia-suicide severity rating scale (C-SSRS) "Since Last Visit" version; b. At baseline, the participant scores >= 5 on the Montgomery-Asberg depression rating scale (MADRS) Item 10 (suicidal Thoughts); c. The participant is considered to be an imminent danger to themself or others based on the assessment of the Investigator
- The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline
- Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study
- The participant has any other condition that may be detrimental to the participant if they participate in the study
- In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study
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-1284ITI-1284 will be administered sublingually. | Drug | ITI-1284 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to Week 52
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
2 secondary outcomes
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Baseline up to Week 52
Change from Baseline in Clinical Global Impression-Severity (CGI S) Score
Time frame: Baseline up to Week 52
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: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ITI-1284 in people with Generalized Anxiety Disorder, run by Intra-Cellular Therapies, Inc. at 3 sites in United States.
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 11 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 3 sites in United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of Participants with Adverse Events (AEs) (time frame: Up to Week 52). 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.