Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
384 (estimated)
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with generalized anxiety disorder. Participants will take a daily dose of SEP-363856 or a placebo for 8 weeks while monitoring their response to the treatment.
Are You a Good Fit for This Trial?
Rules you outHIVHepatitis BHepatitis C
You may be able to join if
I am at least 18 years old.
I have been diagnosed with generalized anxiety disorder.
My body mass index (BMI) is between 18 and 40.
I can follow the study procedures and visit schedule.
I am medically stable as confirmed by my doctor.
I am willing to stop any medications that are not allowed.
If I am a female of childbearing potential, I have a negative pregnancy test and agree to use contraception.
If I am a male, I agree to follow the contraception rules in the study.
You may not be able to join if
I currently have major depression or PTSD.
I have a substance use disorder.
I have a history of certain psychiatric disorders like schizophrenia or bipolar disorder.
I have significant suicide risk or recent suicidal thoughts.
I am taking any medications that are not allowed in the study.
I have taken restricted treatments before.
I am pregnant or breastfeeding.
I have participated in another clinical trial in the past 180 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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Eligibility 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…
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
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