What this study is
The purpose of this study is to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to placebo when given as an additional (adjunctive) therapy in participants with generalized anxiety disorder (GAD; a mental health condition defined by uncontrollable, and excessive worry about everyday events for a long period of time).
What's being tested
- JNJ-99245354
Intervention · DRUG
JNJ-99245354 will be administered sublingually.
- Placebo
Intervention · DRUG
Placebo will be administered sublingually.
Study details
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety, and Tolerability of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment and an Open-label Long-term Extension Treatment With JNJ-99245354 (ITI-1284)
- Sponsor
- Intra-Cellular Therapies, Inc.
- Conditions
- Generalized Anxiety Disorder
- Enrolling
- 705 people
- Starts
- 2026-09-29
- Est. completion
- 2030-09-28
- Design
- Quadruple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at baseline
- Medically stable on the basis of clinical laboratory tests performed at screening
- History of inadequate response to at least 1 generalized anxiety disorder (GAD)-approved treatment taken at an adequate dose and duration as specified in the protocol for the treatment of ongoing GAD symptoms
- Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the double blind (DB) treatment period of the trial
- Body mass index (BMI) within the range 19-40 kilogram per meter squared (kg/m^2) (inclusive)
You can't join if
- Within the participant's lifetime, has one of the following confirmed diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) text revision (TR) psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder
- Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders (except simple phobias and social anxiety disorder); b. moderate or severe alcohol or substance use disorders (excluding nicotine); d. moderate or severe major depressive disorder; e. any other psychiatric condition (except for mild major depressive disorder [MDD]) that has been the main focus of treatment
- Montgomery-asberg depression rating scale (MADRS) total score greater than (>)18 at screening or baseline
- Lifetime history of inadequate response to >3 of the approved treatments for GAD at an adequate dose and for an adequate duration
- The participant is taking more than 1 anti depressive therapy (ADT) or is taking ADT + buspirone at screening, regardless of indication, and is unable or unwilling to discontinue additional ADT (or buspirone) prior to baseline
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openInland Psychiatric Medical Group Inc
Temecula, California, United States
RecruitingNuovida Research Center
Miami, Florida, United States
RecruitingVoltaire Clinical Research
Springfield, Massachusetts, United States
RecruitingFieve Clinical Research Inc
New York, New York, United States
Recruiting
Study team
Sponsor
Intra-Cellular Therapies, Inc.
Study ID 99245354ANX3001
Study director
Intra-Cellular Therapies, Inc. Clinical Trial
Intra-Cellular Therapies, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.