About the ADAPT trial
CVL-865-PA-2001 ADAPT (A Darigabat Panic Disorder Trial) is evaluating darigabat in people living with panic disorder.
In this trial, 1 out of every 2 participants will receive the investigational drug and the other participants will receive placebo. Selection of participants will be performed in a random and blinded manner, which means that neither the participants, nor the trial doctors will know who is getting which treatment. A placebo is a tablet that looks identical to the trial drug but does not contain any active drug.
This trial includes approximately a 28-day screening period followed by a 14-week treatment period and 4 week follow up period.
Science on Darigabat
Darigabat is an investigational medication being studied for panic disorder*. It works by targeting specific parts of the brain called gamma-aminobutyric acid type A (GABAA) receptors, which are thought to regulate brain activity related to panic attacks.
Darigabat has not yet received approval from medical authorities and is still under evaluation for safety and efficacy.
*Darigabat is also under investigation in other indications, unrelated to the ADAPT trial.
About Panic Disorder
Panic disorder is a disorder characterized by recurrent, unexpected panic attacks. These attacks are sudden episodes of intense fear or discomfort that reach a peak within minutes, exhibiting multiple symptoms such as pounding heart, sweating, trembling difficulty of breathing and so on (see list below). Not all individuals experience the same symptoms. Panic disorder can significantly impact an individual’s quality of life, leading to emotional and physical distress and disruption in various aspects of daily functioning.
With proper treatment, individuals diagnosed with panic disorder may experience improvement in their symptoms, a reduction in frequency and severity of panic attacks and improvement in their quality of life, daily and social functioning.
Symptoms that may occur during a panic attack include*:
Skipping, racing or pounding of your heart
Sweating or clammy hands
Trembling or shaking
Shortness of breath or difficulty breathing
Choking sensation or a lump in your throat
Chest pain, pressure or discomfort
Nausea, stomach problems or sudden diarrhea
Feeling dizzy, unsteady, lightheaded or faint
Things around you feeling strange, unreal, detached or unfamiliar. Feeling outside of or detached from part or all of your body
Feeling fear that you are losing control or going crazy
Being afraid that you were dying
Having tingling or numbness in parts of your body
Having hot flushes or chills
Frequency and Duration of Panic Attacks*
The frequency of panic attacks can vary from person to person. Some have occasional attacks while others experience them often, multiple times a week or even daily.
The duration can also vary by individuals and from one episode to the next. Most reach their peak intensity within minutes.
*American Psychiatric Association. Anxiety Disorders. In: Diagnostic and Statistical Manual of Mental Disorders.
5th ed. Text Revision. American Psychiatric Association; 2022: pp. 215-231.
Who is Eligible?
- Adults aged 18–65 years old
- Current primary diagnosis of panic disorder for at least 6 months
- Experience of at least 8 panic attacks in the month prior to the screening
- No severe secondary psychiatric illness or other medical conditions.
*This is not an exhaustive list. A full evaluation will be conducted by the study location.
If you or someone you know may be eligible the ADAPT trial, please contact a participating site for further evaluation.
Find a Study Location
To begin your search choose for the ADAPT trial, enter your address and/or zip code.
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Interested in becoming a study location?
Contact us at: cerevelclinicaltrials@cerevel.com
Frequently Asked Questions
Clinical research trials, also known as clinical studies, are scientific investigations that shape the future of medicine by helping to find:
- New medicines
- Better formulations of existing medicines
- New uses for existing medicines
Before introducing new medicine to the public, pharmaceutical companies must test their investigational drugs very carefully through approved medical research trials (also called “clinical studies”). Trial doctors are required to follow strict rules to protect the safety of the people who volunteer to participate in research trials. Participants may or may not benefit from the investigational drug. All researchers must follow a detailed plan, called a protocol, which explains all trial procedures. Protocols are reviewed by an independent board (or group of people) that oversees the safety of all trial participants. Additionally, before enrolling individuals into a trial, researchers must fully explain the trial to the individual and answer any questions they may have. Participation in a research trial is voluntary and individuals may withdraw from the trial at any time for any reason.
Global regulatory agencies, such as the United States Food and Drug Administration (FDA), thoroughly review the data collected in these trials before authorizing new medications for the public. Once a drug is authorized, many pharmaceutical companies continue to conduct research on the authorized drug to collect ongoing safety and effectiveness data.
The trial doctor and staff will review a potential participant’s medical history to determine eligibility to participate. If eligible, the participant will be asked to read and sign an Informed Consent Form. This form contains information about the trial, a summary of what may be expected during the trial participation, potential risks and benefits, the rights of trial participants and other options that may be available to the participant.
Participating in a research trial helps the pharmaceutical and medical communities to discover potential new treatments. Without volunteers like you, these trials would not be possible. We understand being in a trial may involve more interaction with healthcare providers than usual. It will require a time commitment and require you to travel and participate in various medical and data collection procedures.
Participation in ADAPT lasts approximately 25 weeks.
A stipend is provided to cover the costs for time spent in the clinic during the treatment period and any travel expenses. Additionally, all examinations, evaluations and treatments associated with the ADAPT trial are provided at no cost.