A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder
Recruiting · NCT07767903 · Interventional (participants receive a specific treatment) · Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSEP-363856
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female participants at least 18 years of age at the time of informed consent
- 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
- Body Mass Index (BMI) 18-40 kilograms per square meter (kg/m\^2)
- Participant is willing and able to comply with study procedures and visit schedule
- Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests and able to comply with study procedures
- Willing and able to discontinue prohibited medications/therapies per protocol
- (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
- Willing and able to discontinue prohibited medications/therapies per protocol
- Key
Exclusion criteria
- 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
- Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening
- Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)
- Significant suicide risk e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale \[C-SSRS\] or MADRS)
- Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)
- Prior exposure to restricted treatments
- Pregnant or breastfeeding females
- Participation in another investigational study within 180 days (or more than \[\>\] 1 trial in last year)
- Known history of human immunodeficiency virus seropositivity, hepatitis B or C
Where it is running
5 locations listed across 5 US states.
- Anderson Clinical Research - Redlands, California, United States
- Clinical Neuroscience Solutions Inc. (CNS) - Orlando - Orlando, Florida, United States
- Lumina Clinical Research Center - Cherry Hill, New Jersey, United States
- Basil Clinical - Jamaica, New York, United States
- Core Clinical Research - Everett, Washington, United States