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
576 (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 either the study drug or a placebo for 8 weeks and attend regular check-ups during that time.
Are You a Good Fit for This Trial?
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 am willing to follow the study procedures and visit schedule.
I am medically stable based on my health history and tests.
I can stop taking prohibited medications before and during the trial.
I can use acceptable contraception if I am a female of childbearing potential.
I agree to follow the contraception requirements if I am male.
You may not be able to join if
I have a current diagnosis of major depression or PTSD.
I have a substance use disorder within the last year.
I have a lifetime history of certain serious psychiatric disorders.
I am at significant risk of suicide.
I have taken prohibited medications in the past few weeks.
I have been pregnant or breastfeeding.
I have participated in another study in the last 180 days.
I have a known history of HIV, hepatitis B, or hepatitis C.
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, 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.
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 Generalized Anxiety Disorder (GAD) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatr…
Key Inclusion Criteria:
1. Male or female participants at least 18 years of age at the time of informed consent
2. 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
3. Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\^2) (inclusive)
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
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. 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:
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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