Generalized Anxiety Disorder
Conditions
Brief summary
The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.
Interventions
DRUGITI-1284
ITI-1284 will be administered sublingually.
Sponsors
Intra-Cellular Therapies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Roll-over participants: * Provide written informed consent before the initiation of any study specific procedures * Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study * Male or female of childbearing potential and agrees to use a highly effective method of birth control from the time informed consent is provided until 30 days after the last dose of ITI-1284 for females and 90 days after the last dose of ITI-1284 for males * Ability to follow study instructions and likely to complete all required visits * In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302) * If entering from lead-in study ITI-1284-301, must be expected to continue their ongoing anti-depressant therapy (ADT) or buspirone from the lead-in study Inclusion criteria for De-novo participants: * Provide written informed consent before the initiation of any study-specific procedures * Male or female participants greater than or equal to (\>=) 18 years of age * Has a body mass index (BMI) of 19-40 kilogram per meter squared (kg/m\^2), inclusive * At screening, meet diagnostic and statistical manual of mental disorders, fifth edition, text revision (DSM-5-TR) diagnostic criteria for moderate or severe generalized anxiety disorder (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) * Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study
Exclusion criteria
for Roll-over participants * In the opinion of the Investigator, the participant has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or: a. At baseline, the participant scores "yes" on suicidal Ideation Items 4 or 5 of the Columbia-suicide severity rating scale (C-SSRS) "Since Last Visit" version; b. At baseline, the participant scores \>= 5 on the Montgomery-Asberg depression rating scale (MADRS) Item 10 (suicidal Thoughts); c. The participant is considered to be an imminent danger to themself or others based on the assessment of the Investigator * The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline * Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study * The participant has any other condition that may be detrimental to the participant if they participate in the study * In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to Week 52 | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Baseline up to Week 52 | The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is rated on a 5-point scale ranging from 0 = not present to 4 = very severe, disabling symptoms. The HAM A total score ranges from 0 to 56 where higher score indicates greater severity in symptoms. |
| Change from Baseline in Clinical Global Impression-Severity (CGI S) Score | Baseline up to Week 52 | The CGI-S scale is a standardized assessment tool that the clinician can use to rate the overall severity of illness. The CGI-S asks the clinician: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on the following seven-point scale: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. Higher scores indicate worse outcome. |
Countries
United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORIntra-Cellular Therapies, Inc. Clinical Trial
Intra-Cellular Therapies, Inc.
Outcome results
None listed