What side effects are associated with this type of intervention?

Common treatments for Panic Disorder that involve GABA-A receptor modulation, such as benzodiazepines, can cause side effects including drowsiness, dizziness, impaired coordination, and dependency with long-term use. Other pharmacotherapies like SSRIs and SNRIs, which are also commonly used, may cause nausea, headache, sexual dysfunction, and insomnia. It's important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Panic Disorder, primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as paroxetine, sertraline, and fluoxetine, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine. Benzodiazepines, which also modulate GABA-A receptors, such as alprazolam and clonazepam, have been approved for short-term management due to their rapid onset of action. These treatments aim to reduce the frequency and severity of panic attacks and associated anxiety symptoms.

What other types of research exist?

Promising novel alternatives to Darigabat for panic disorder patients include clomipramine and imipramine, which have shown marked efficacy in reducing panic attacks and phobic avoidance. Additionally, cognitive-behavioral therapy (CBT) remains a highly effective non-pharmacological treatment. Emerging treatments such as buspirone and pregabalin, which have shown efficacy in related anxiety disorders, may also be considered.

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GABA receptor modulator

Darigabat for Panic Disorder

Phase 2

Recruiting

Research Sponsored by Cerevel Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing if taking darigabat regularly can help people with panic disorder by calming their brain activity to reduce panic attacks.

Who is the study for?

This trial is for adults with a primary diagnosis of panic disorder, having had at least 8 panic attacks in the past month and no week without panic attacks. They must have a certain body weight and BMI, and not be undergoing any new psychotherapy or have significant psychiatric comorbidities or serious health issues.

What is being tested?

The study tests the effectiveness, safety, and tolerability of darigabat (25 mg twice daily) against a placebo in individuals with panic disorder. Participants will randomly receive either darigabat or placebo to compare outcomes.

What are the potential side effects?

While specific side effects are not listed here, generally such trials monitor for adverse reactions like nausea, headaches, dizziness, potential mood changes or other physical symptoms that could arise from taking medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DarigabatExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Darigabat

2023

Completed Phase 1

~30

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Panic Disorder treatments often target neurotransmitter systems to alleviate symptoms. Darigabat, like other GABA-A receptor modulators, enhances the inhibitory effects of GABA, the brain's primary inhibitory neurotransmitter, which helps reduce neuronal excitability and anxiety. This mechanism is crucial for Panic Disorder patients as it can help prevent the sudden onset of panic attacks. Additionally, SSRIs and SNRIs, which are commonly used, increase serotonin and norepinephrine levels, respectively, to improve mood and reduce anxiety. Understanding these mechanisms helps in selecting appropriate treatments tailored to individual patient needs, potentially improving outcomes and quality of life.