Overview
A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder
Status:
Recruiting
Recruiting
Trial end date:
2025-04-01
2025-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Cerevel Therapeutics, LLC
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