Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
Recruiting · NCT06480383 · 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 evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.
Who can take part
Age range
No age limits stated
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;
- Male or female patients ≥ 18 years of age;
- 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 1 GAD-approved treatment (ie, one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 milligrams \[mg\], venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;
- Currently having an inadequate response to one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) and agrees to continue the same dosing regimen for the duration of the study.
- NOTE: The current GAD-approved treatment must be different from the GAD treatment identified as the historical failure.
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 (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks).
Where it is running
56 locations listed across 11 US states.
- Behavioral Research Specialists LLC - Glendale, California, United States
- Sun Valley Research Center - Imperial, California, United States
- Synergy East - Lemon Grove, California, United States
- Excell Research Inc - Oceanside, California, United States
- NRC Research Institute - Orange, California, United States
- Anderson Clinical Research - Redlands, California, United States
- Premier Clinical Research - Miami, Florida, United States
- Global Medical Institutes - Miami, Florida, United States
- Miami Dade Medical Research Institute - Miami, Florida, United States
- Sunshine Medical Solution - Miami, Florida, United States
- South Florida Research Inc - Miami Springs, Florida, United States
- K2 Medical Research - Tampa, Florida, United States
- CenExeli Research LLC - Atlanta, Georgia, United States
- Atlanta Center for Medical Research - Atlanta, Georgia, United States
- Michigan Clinical Research Institute - Ann Arbor, Michigan, United States
- Bio Behavioral Health - Toms River, New Jersey, United States
- SPRI Clinical Trials, LLC - Brooklyn, New York, United States
- Neuro Behavioral Clinical Research - North Canton, Ohio, United States
- Sooner Clinical Research - Oklahoma City, Oklahoma, United States
- Lehigh Center for Clinical Research LLC - Allentown, Pennsylvania, United States
- Suburban Research Associates - Media, Pennsylvania, United States
- Austin Clinical Trial Partners - Austin, Texas, United States
- BioBehavioral Research of Austin PC - Austin, Texas, United States
- Aims Trials LLC - Plano, Texas, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Institute of Mental Health Serbia - Belgrade, Serbia
- University Clinical Center of Serbia 1 - Belgrade, Serbia
- University Clinical Center of Serbia - Belgrade, Serbia
- University Clinical Hospital Center Dr Dragisa Misovic- Dedi - Belgrade, Serbia
- Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk - Bialystok, Poland
- Medical Center Sv Dimitar Blagoevgrad - Blagoevgrad, Bulgaria
- Medipa S R O - Brno, Czechia
- Mental Health Center Prof. Dr. Ivan Temkov - Burgas, Bulgaria
- Przychodnia Srodmiescie SP. z o.o. - Bydgoszcz, Poland
- Specjalistyczna Praktyka Lekarska Piotr Zalitacz - Gorlice, Poland
- Special Neuropsychiatric Hospital Kovin - Kovin, Serbia
- University Clinical Center Kragujevac - Kragujevac, Serbia
- Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS - Leszno, Poland
- Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi - Novi Kneževac, Serbia
- A Shine S R O - Pilsen, Czechia
- Outpatient care-group practice for specialized psychiatric care Datamed OOD - Pleven, Bulgaria
- Medical Center Mentalcare OOD - Plovdiv, Bulgaria
- Filip Rybakowski Specjalistyczna Praktyka Lekarska - Poznan, Poland
- Clintrial s r o - Prague, Czechia
- Medical Services Prague S R O - Prague, Czechia
- Institut Neuropsychiatricke pece - Prague, Czechia
- Mental Health Center - Rousse - Rousse, Bulgaria
- Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum - Sofia, 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
- Medical center - VAS OOD - Targovishte, Bulgaria
- Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed - Torun, Poland
- Diagnostic Consulting Center Mladost - M Varna 1 - Varna, Bulgaria
- Diagnostic Consulting Center Mladost - M Varna - Varna, Bulgaria
- Mental Health Center - Vratsa EOOD - Vratsa, Bulgaria