Generalized Anxiety Disorder
Conditions
Keywords
Generalized Anxiety Disorder, GAD, Anxiety
Brief summary
This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day \[mg/day\]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).
Interventions
DRUGSEP-363856
Oral tablet
DRUGPlacebo
Oral tablet
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria 1. Male or female participants at least 18 years of age at the time of informed consent 2. Primary diagnosis of GAD per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation 3. Body Mass Index (BMI) 18-40 kilograms per square meter (kg/m\^2) 4. Participant is willing and able to comply with study procedures and visit schedule 5. Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests and able to comply with study procedures 6. Willing and able to discontinue prohibited medications/therapies per protocol 7. (i ) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception (ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions 8. Willing and able to discontinue prohibited medications/therapies per protocol Key
Exclusion criteria
1. Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening 2. Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening 3. Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder) 4. Significant suicide risk e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale \[C-SSRS\] or MADRS) 5. Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments) 6. Prior exposure to restricted treatments 7. Pregnant or breastfeeding females 8. Participation in another investigational study within 180 days (or more than \[\>\] 1 trial in last year) 9. Known history of human immunodeficiency virus seropositivity, hepatitis B or C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Baseline, Week 8 | The HAM-A is a clinician-administered rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is scored on a 5-point Likert-type scale ranging from 0 (absent) to 4 (very severe). The total score ranges from 0 to 56, with higher scores indicating greater severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Week 8 in Clinical Global Impression-Severity (CGI-S) Score | Baseline, Week 8 | The CGI-S is a clinician-rated assessment of the participant's current illness state on a 7-point Likert-type scale (1=normal, not at all ill; 7=among the most extremely ill patients), where a higher score is associated with greater illness severity. A decrease in value indicates improvement. |
| Proportion of Participants Achieving HAM-A Response Criterion at Week 8 (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline in HAM-A Total Score) | Baseline, Week 8 | — |
Countries
United States
Contacts
CONTACTOtsuka Call Center
Outcome results
None listed