Generalized Anxiety Disorder
Conditions
Keywords
Generalized Anxiety Disorder, GAD, Anxiety
Brief summary
This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.
Interventions
DRUGSEP-363856
Oral tablet
Sponsors
Otsuka Pharmaceutical Development & Commercialization, 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
Key Inclusion Criteria 1. Male or female participants at least 18 years of age at the time of informed consent 2. Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention 3. Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856 4. Participant is willing and able to comply with study procedures and visit schedule 5. 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 Key
Exclusion criteria
1. Diagnosis other than GAD that is the primary focus of treatment 2. Clinically significant psychiatric or medical condition that may interfere with study participation 3. Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes 4. Clinically significant abnormal laboratory values or ECG findings 5. Significant suicide risk 6. Substance use/positive drug screen 7. Use of prohibited medications/therapies 8. Known sensitivity to SEP-363856
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation | Throughout the trial (up to Week 27) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score | Baseline, Weeks 8, 14, and 26 | 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 participants), where a higher score is associated with greater illness severity. A decrease in value indicates improvement. |
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Baseline, Weeks 8, 14, and 26 | 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. |
Contacts
CONTACTOtsuka Call Center
Outcome results
None listed