Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
Recruiting · NCT06701903 · Interventional (participants receive a specific treatment) · Lead sponsor: Intra-Cellular Therapies, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
ITI-1284 10 mgITI-1284 20 mgPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
51 locations listed across 13 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Woodland International Research Group - Little Rock, Arkansas, United States
- Woodland Research Northwest - Rogers, Arkansas, United States
- Proscience Research Group - Culver City, California, United States
- Leading Edge Research - Encino, California, United States
- Wake Research PRI Encino - Encino, California, United States
- CalNeuro Research - Los Angeles, California, United States
- Excell Research Inc - Oceanside, California, United States
- California Neuroscience Research - Sherman Oaks, California, United States
- Pacific Clinical Research Medical Group - Upland, California, United States
- Sunwise Clinical Research - Walnut Creek, California, United States
- University of Connecticut Health Center - Farmington, Connecticut, United States
- Sarkis Clinical Trials - Gainesville, Florida, United States
- Miami Dade Medical Research Institute - Miami, Florida, United States
- University of South Florida - Tampa, Florida, United States
- iResearch Atlanta LLC - Decatur, Georgia, United States
- Precise Clinical Research, Inc. - Flowood, Mississippi, United States
- SPRI Clinical Trials, LLC - Brooklyn, New York, United States
- University of Buffalo - Buffalo, New York, United States
- Richmond Behavioral Associates - Staten Island, New York, United States
- The Ohio State University - Columbus, Ohio, United States
- Sooner Clinical Research - Oklahoma City, Oklahoma, United States
- Suburban Research Associates - Media, Pennsylvania, United States
- Relaro Medical Trials - Dallas, Texas, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Clinical Center Dr Dragisa Misovic Dedinje - Belgrade, Serbia
- Institute of Mental Health Serbia - Belgrade, Serbia
- University Clinical Center of Serbia 1 - Belgrade, Serbia
- University Clinical Center of Serbia - Belgrade, Serbia
- Prywatne Gabinety Lekarskie PROMEDICUS - Bialystok, Poland
- Medical Center Sv Dimitar Blagoevgrad - Blagoevgrad, Bulgaria
- Psychiatricka Ambulancia Mentum S.R.O. - Bratislava, Slovakia
- Przychodnia Srodmiescie SP. z o.o. - Bydgoszcz, Poland
- Centrum Zdrowia Alcea - Gdansk, Poland
- Medical Center Lifemed - Kardzhali, Bulgaria
- Special Neuropsychiatric Hospital Kovin - Kovin, Serbia
- University Clinical Center Kragujevac - Kragujevac, Serbia
- Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS - Leszno, Poland
- University Clinical Center NIS - Niš, Serbia
- Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi - Novi Kneževac, Serbia
- Medical Center Medconsult-Pleven - Pleven, Bulgaria
- Medical Center Mentalcare OOD - Plovdiv, Bulgaria
- Psychiatricka Ambulancia Psycholine S.R.O. - Rimavská Sobota, Slovakia
- Mental Health Center - Rousse - Rousse, Bulgaria
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD - Sofia, Bulgaria
- Medical Center Hera EOOD - Sofia, Bulgaria
- Medical Center Intermedica, OOD - Sofia, Bulgaria
- Centrum Zdravia R.B.K. S.R.O. Poliklinika Medic Sk - Svidník, Slovakia
- Medical center - VAS OOD - Targovishte, Bulgaria
- Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed - Torun, Poland
- Crystal Comfort s.r.o. - Vranov nad Topľou, Slovakia