Status and phase
Conditions
Treatments
About
The purpose of this trial is to measure the efficacy, safety, and tolerability of darigabat (25 milligrams [mg] twice daily [BID]) compared with placebo in participants with panic disorder.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Participants who have a current significant psychiatric comorbidity
Any newly initiated evidence-based psychotherapy, including cognitive behavioral therapy (CBT)
Any exposure-based therapy is prohibited throughout the duration of the trial
Participants with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease
Participants who answer "Yes" on the following C-SSRS Suicidal Ideation Items (within the last 6 months)
NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Primary purpose
Allocation
Interventional model
Masking
246 participants in 2 patient groups, including a placebo group
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Central trial contact
Cerevel Clinical Trial Support
Data sourced from clinicaltrials.gov
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