A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder

Ki vehet részt

• Primary diagnosis of panic disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR), as confirmed by the Standard Mini International Neuropsychiatric Interview (MINI)
• Participant has had a minimum of 8 panic attacks, with no week free of panic attacks, in the month prior to the Screening Visit. In the 2 weeks prior to the Baseline Visit, the participant must have had at least 4 panic attacks and no week free of panic attacks
• Participants with a PDSS total score ≥12 at the Screening and Baseline Visits
• Body mass index of 17.5 to 40.0 kilograms per meter square (kg/m2) and a total body weight >48 kg at Screening

Ki nem vehet részt

• Any newly initiated evidence-based psychotherapy, including cognitive behavioral therapy (CBT)
• Any exposure-based therapy is prohibited throughout the duration of the trial
• Participants who have a current significant psychiatric comorbidity
• 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); Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) OR; Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) OR Participants who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (within the last 2 years); Any of the Suicidal Behavior items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) OR; Participants who, in the opinion of the investigator, present a serious risk of suicide; NOTE: Other protocol-defined inclusion/exclusion criteria may apply