Are clinical trials safe?

Yes. Every study on QualifiedStudies is reviewed and approved by an Institutional Review Board (IRB) and conducted under FDA regulations. Research sites are HIPAA-covered entities, and you can withdraw at any time for any reason.

Do I get paid to participate in a clinical trial?

Most studies offer compensation for your time and travel. The amount varies by study length and visit schedule, and is disclosed up front before you enroll.

Is my health information kept private?

Yes. Your information is encrypted, never sold, and only shared with the specific research site you choose to apply to. Our handling of your data is governed by our Consumer Health Data Privacy Policy; the research sites you're matched with are HIPAA-covered entities.

How do I qualify for a clinical trial?

Take our free 60-second eligibility quiz. Enter your ZIP code, condition, and a few health details, and we'll match you with research sites near you that are actively enrolling participants.

Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder

NCT ID: NCT06701903
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Intra-Cellular Therapies, Inc.
Conditions: Generalized Anxiety Disorder

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 570 participants (Estimated).

What is being studied

Drug: ITI-1284 10 mg
Drug: ITI-1284 20 mg
Drug: Placebo

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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)

Study locations

51 study locations are listed.

Recruiting site status is explicitly provided for 51 locations; 49 are listed as Recruiting.

Countries: Bulgaria, Poland, Serbia, Slovakia, United States

Alabama, United States: 1
Arkansas, United States: 2
California, United States: 8
Connecticut, United States: 1
Florida, United States: 3
Georgia, United States: 1
Mississippi, United States: 1
New York, United States: 3
Ohio, United States: 1
Oklahoma, United States: 1
Pennsylvania, United States: 1
Texas, United States: 1
Washington, United States: 1

Sample of listed locations

Medical Center Sv Dimitar Blagoevgrad — Blagoevgrad, 2700, Bulgaria — Recruiting
Medical Center Lifemed — Kardzhali, 6600, Bulgaria — Recruiting
Medical Center Medconsult-Pleven — Pleven, 5800, Bulgaria — Recruiting
Medical Center Mentalcare OOD — Plovdiv, 4004, Bulgaria — Recruiting
Mental Health Center - Rousse — Rousse, 7003, Bulgaria — Recruiting
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD — Sofia, 1408, Bulgaria — Recruiting
Medical Center Hera EOOD — Sofia, 1510, Bulgaria — Recruiting
Medical Center Intermedica, OOD — Sofia, 1680, Bulgaria — Recruiting
Medical center - VAS OOD — Targovishte, 7700, Bulgaria — Recruiting
Prywatne Gabinety Lekarskie PROMEDICUS — Bialystok, 15272, Poland — Recruiting
Przychodnia Srodmiescie SP. z o.o. — Bydgoszcz, 85-080, Poland — Recruiting
Centrum Zdrowia Alcea — Gdansk, 80 283, Poland — Recruiting
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS — Leszno, 64-100, Poland — Recruiting
Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed — Torun, 87 100, Poland — Recruiting
Clinical Center Dr Dragisa Misovic Dedinje — Belgrade, 11000, Serbia — Recruiting
Institute of Mental Health Serbia — Belgrade, 11000, Serbia — Recruiting
University Clinical Center of Serbia — Belgrade, 11000, Serbia — Recruiting
University Clinical Center of Serbia 1 — Belgrade, 11000, Serbia — Recruiting
Special Neuropsychiatric Hospital Kovin — Kovin, 26220, Serbia — Recruiting
University Clinical Center Kragujevac — Kragujevac, 34000, Serbia — Recruiting
University Clinical Center NIS — Niš, 18000, Serbia — Recruiting
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi — Novi Kneževac, 23330, Serbia — Recruiting
Psychiatricka Ambulancia Mentum S.R.O. — Bratislava, 821 01, Slovakia — Recruiting
Psychiatricka Ambulancia Psycholine S.R.O. — Rimavská Sobota, 979 01, Slovakia — Recruiting
Centrum Zdravia R.B.K. S.R.O. Poliklinika Medic Sk — Svidník, 08901, Slovakia — Recruiting

Study details

Start date: November 21, 2024
Primary completion date: October 14, 2027
Completion date: July 20, 2028
First posted: November 22, 2024

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06701903
Registry last updated: September 25, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT06701903 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

About joining clinical research

Find clinical trials you may match with

QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.

Find clinical trials you may match with | Clinical trial FAQ