NCT06701903 Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
| NCT ID | NCT06701903 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Intra-Cellular Therapies, Inc. |
| Condition | Generalized Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 570 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2027-10-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 570 participants in total. It began in 2024-11-21 with a primary completion date of 2027-10-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 inadequate response to generalized anxiety disorder treatment.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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)
Contact & Investigator
Intra-Cellular Therapies,Inc. Clinical Trial
STUDY DIRECTOR
Intra-Cellular Therapies, Inc.
Frequently Asked Questions
Who can join the NCT06701903 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Generalized Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06701903 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06701903 currently recruiting?
Yes, NCT06701903 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT06701903 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Rogers, United States, Culver City, United States and 11 additional locations.
Who is sponsoring the NCT06701903 clinical trial?
NCT06701903 is sponsored by Intra-Cellular Therapies, Inc.. The principal investigator is Intra-Cellular Therapies,Inc. Clinical Trial at Intra-Cellular Therapies, Inc.. The trial plans to enroll 570 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.