Phase
Condition
Anxiety Disorders
Mood Disorders
Treatment
Darigabat
Placebo
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Primary diagnosis of panic disorder based on Diagnostic and Statistical Manual ofMental Disorders, Fifth Edition Text Revision (DSM-5-TR), as confirmed by theStandard Mini International Neuropsychiatric Interview (MINI)
Participant has had a minimum of 8 panic attacks, with no week free of panicattacks, in the month prior to the Screening Visit. In the 2 weeks prior to theBaseline Visit, the participant must have had at least 4 panic attacks and no weekfree 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 bodyweight >48 kg at Screening
Exclusion
Exclusion Criteria:
Participants who have a current significant psychiatric comorbidity
Any newly initiated evidence-based psychotherapy, including cognitive behavioraltherapy (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, orneurological 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 andIntent) OR Participants who answer "Yes" on any of the 5 C-SSRS SuicidalBehavior 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 ofsuicide
NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Study Design
Connect with a study center
Phoenix, Arizona
Phoenix, Arizona 85012
United StatesSite Not Available
Bryant, Arkansas
Bryant, Arkansas 72022
United StatesSite Not Available
Lafayette, California
Lafayette, California 94549
United StatesSite Not Available
Los Angeles, California
Los Angeles, California 90025
United StatesSite Not Available
Oceanside, California
Oceanside, California 92056
United StatesSite Not Available
Orange, California
Orange, California 92868
United StatesSite Not Available
Riverside, California
Riverside, California 92506
United StatesSite Not Available
San Jose, California
San Jose, California 95124
United StatesSite Not Available
Torrance, California
Torrance, California 90502
United StatesSite Not Available
Miami, Florida
Miami, Florida 33175
United StatesSite Not Available
North Miami Beach, Florida
North Miami Beach, Florida 33162
United StatesSite Not Available
Orlando, Florida
Orlando, Florida 32807
United StatesSite Not Available
Atlanta, Georgia
Atlanta, Georgia 30331
United StatesSite Not Available
Decatur, Georgia
Decatur, Georgia 30030
United StatesSite Not Available
Savannah, Georgia
Savannah, Georgia 31405
United StatesSite Not Available
Elgin, Illinois
Elgin, Illinois 60123
United StatesSite Not Available
Overland Park, Kansas
Overland Park, Kansas 66210
United StatesSite Not Available
Boston, Massachusetts
Boston, Massachusetts 02131
United StatesSite Not Available
Las Vegas, Nevada
Las Vegas, Nevada 89102
United StatesSite Not Available
Berlin, New Jersey
Berlin, New Jersey 08009
United StatesSite Not Available
Brooklyn, New York
Brooklyn, New York 11229
United StatesSite Not Available
New York, New York
New York, New York 10016
United StatesSite Not Available
Rochester, New York
Rochester, New York 14618
United StatesSite Not Available
Staten Island, New York
Staten Island, New York 10314
United StatesSite Not Available
Monroe, North Carolina
Monroe, North Carolina 28112
United StatesSite Not Available
Oklahoma City, Oklahoma
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
West Chester, Pennsylvania
West Chester, Pennsylvania 19380
United StatesSite Not Available
Austin, Texas
Austin, Texas 78737
United StatesSite Not Available
Dallas, Texas
Dallas, Texas 75231
United StatesSite Not Available
Desoto, Texas
DeSoto, Texas 75115
United StatesSite Not Available
Draper, Utah
Draper, Utah 84020
United StatesSite Not Available
Everett, Washington
Everett, Washington 98201
United StatesSite Not Available
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