A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder
Panic Disorder
About this trial
This is an interventional treatment trial for Panic Disorder
Eligibility Criteria
Inclusion Criteria: 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 Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders 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 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) 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
Sites / Locations
- Phoenix, ArizonaRecruiting
- Lafayette, CaliforniaRecruiting
- Los Angeles, California
- Riverside, CaliforniaRecruiting
- Torrance, CaliforniaRecruiting
- Miami, FloridaRecruiting
- Orlando, FloridaRecruiting
- Atlanta, GeorgiaRecruiting
- Decatur, GeorgiaRecruiting
- Savannah, GeorgiaRecruiting
- Overland Park, KansasRecruiting
- Boston, MassachusettsRecruiting
- Las Vegas, NevadaRecruiting
- Berlin, New JerseyRecruiting
- Brooklyn, New YorkRecruiting
- Brooklyn, New YorkRecruiting
- Rochester, New YorkRecruiting
- Staten Island, New YorkRecruiting
- West Chester, PennsylvaniaRecruiting
- Austin, TexasRecruiting
- Dallas, TexasRecruiting
- Draper, UtahRecruiting
- Everett, WashingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Darigabat
Placebo
Participants will receive darigabat, up to a maximum dose of 12.5 mg, orally, BID, for two weeks in the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks in the Maintenance Treatment Period.
Participants will receive darigabat matching placebo, orally, BID for 2 weeks during the Titration period and thereafter for 12 weeks during the Maintenance Treatment Period.