Trial studying safety and effects for Generalized Anxiety Disorder
Official title A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder
ClinicalTrials.gov ID: NCT07767903
What this study is testing
What is SEP-363856?
SEP-363856 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for generalized anxiety disorder.
Also referred to as Ulotaront.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key 1. 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...
- 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
You likely can't join if
- Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the...
- 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...
- 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...
- Prior exposure to restricted treatments
See the full eligibility criteria
- Key 1. 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Redlands, California, United States
- Orlando, Florida, United States
- Cherry Hill, New Jersey, United States
- Jamaica, New York, United States
- Everett, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redlands, California, United States; Orlando, Florida, United States; Cherry Hill, New Jersey, United States; Jamaica, New York, United States; Everett, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.