A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder
Recruiting · NCT07759128 · 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, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.
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 Generalized Anxiety Disorder (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) between 18 and 40 kilograms per square meter (kg/m\^2) (inclusive)
- 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
- 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
- Participant is willing and able to safely discontinue all prohibited medications/therapies/herbal supplements in accordance with the protocol-required washouts prior to baseline/Day 1 and during the trial period.
- 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
3 locations listed across 3 US states.
- Clinical Neuroscience Solutions, LLC - Jacksonville, Florida, United States
- Manhattan Behavioral Medicine PLLC - New York, New York, United States
- FutureSearch Trials of Dallas - Dallas, Texas, United States