Darigabat for Panic Disorder

No longer recruiting at 30 trial locations

Overseen By Theresa Pham

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Psychiatric comorbidity, Cardiovascular, Neurological, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication called darigabat to determine if it reduces symptoms in people with panic disorder. The study compares darigabat to a placebo (a pill with no active medicine) to evaluate its effectiveness, safety, and tolerability. Suitable candidates for this trial include those diagnosed with panic disorder who have experienced frequent panic attacks, with at least eight in the past month. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important early findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that darigabat is likely to be safe for humans?

Research shows that darigabat is being tested for safety and tolerability in people with panic disorder. Earlier studies found that doses similar to those in the current trial were generally well-tolerated. For example, past research demonstrated that taking 7.5 mg and 25 mg doses twice a day yielded positive results without serious safety issues.

While these findings are promising, it's important to note that this treatment is still in the early stages of testing specifically for panic disorder. Although initial results are encouraging, further research is needed to fully understand its safety for this condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for panic disorder?

Most treatments for panic disorder focus on managing symptoms through medications like SSRIs, SNRIs, or benzodiazepines. Darigabat is unique because it targets the GABA-A receptor in a novel way, potentially offering a more targeted approach to reducing anxiety and panic symptoms. Researchers are excited about darigabat because it may provide faster relief with fewer side effects compared to traditional medications. Additionally, its unique mechanism may make it effective for patients who don't respond well to current treatments.

What evidence suggests that darigabat might be an effective treatment for panic disorder?

Research has shown that darigabat may help reduce symptoms of panic disorder. In earlier studies, taking either 7.5 mg or 25 mg doses of darigabat led to noticeable improvements in panic symptoms. Participants reported feeling less panic and fear after using darigabat. These results suggest that darigabat could effectively manage panic disorder symptoms. In this trial, participants will receive either darigabat or a placebo to further evaluate its effectiveness. ^{1 2 4 5 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with panic disorder.

Minimum of 8 panic attacks in the month prior to Screening Visit, with no week free of panic attacks. At least 4 panic attacks in the 2 weeks prior to Baseline Visit, with no week free of panic attacks

PDSS total score ≥12 at Screening and Baseline Visits

Exclusion Criteria

I do not have any major heart, lung, stomach, kidney, liver, blood, immune system, or brain diseases.

I have recently started a recognized therapy like CBT.

Current significant psychiatric comorbidity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Titration

Participants receive darigabat or placebo, up to a maximum dose of 12.5 mg, orally, BID for two weeks

2 weeks

Maintenance Treatment

Participants receive darigabat 25 mg or placebo, orally, BID for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Darigabat

Trial Overview

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.

How Is the Trial Designed?

Group I: Darigabat Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Cerevel Therapeutics, LLC

Lead Sponsor

Trials

37

Recruited

5,500+

Published Research Related to This Trial

At least 75% of patients with panic disorder respond well to three classes of medications (tricyclic antidepressants, monoamine oxidase inhibitors, benzodiazepines), which have similar efficacy and side effects, especially when combined with cognitive and behavioral techniques.

Both pharmacological and cognitive-behavioral treatments are effective in reducing symptoms of panic disorder, with psychosocial treatments showing advantages like lower relapse rates, highlighting the importance of comprehensive treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Panic disorder: efficacy of current treatments. Ballenger, JC.[2009]

Panic disorder is often chronic and associated with various psychiatric issues, making effective treatment challenging due to side effects of traditional medications.

Recent research suggests that panic disorder is linked to problems with serotonin in the brain, indicating that selective serotonin reuptake inhibitors (SSRIs) may be a better first-line treatment option due to their lower side effects compared to older medications like tricyclic antidepressants and benzodiazepines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The place of selective serotonin reuptake inhibitors in the treatment of panic disorder. DeVane, CL.[2022]

Panic disorder is characterized by recurrent, unexpected panic attacks and can lead to significant behavioral changes and anticipatory anxiety, making early diagnosis crucial for effective treatment.

Both pharmacologic and non-pharmacologic cognitive-behavioral therapies have been shown to be safe and effective in treating panic disorder, helping patients regain confidence and improve their daily functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Panic disorder: effective treatment options. Saeed, SA., Bruce, TJ.[2007]

Quetiapine extended-release was not effective in treating treatment-resistant panic disorder compared to a placebo, indicating that it may not be a viable option for patients who do not respond to standard treatments.

Switching from cognitive behavioral therapy (CBT) to medications like paroxetine or citalopram has shown better outcomes for patients who did not respond to CBT, suggesting that a change in treatment strategy can be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Treatment-Resistant Panic Disorder. Perna, G., Caldirola, D.[2022]

In a pilot study involving 19 patients with panic disorder, the GABA reuptake inhibitor tiagabine (TGB) did not show significant clinical benefits compared to placebo over 4 weeks, as measured by standard anxiety rating scales.

However, TGB-treated patients exhibited decreased sensitivity to panic-inducing challenges, suggesting that while it may not alleviate symptoms directly, it could influence the physiological response to panic triggers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the GABA-reuptake inhibitor tiagabine on panic and anxiety in patients with panic disorder. Zwanzger, P., Eser, D., Nothdurfter, C., et al.[2018]

In an 8-week trial involving 10 patients with refractory panic disorder, olanzapine significantly reduced the average number of panic attacks from 6.1 per week to 1.1, with 50% of participants becoming panic-free by the end of treatment.

The study found that olanzapine was generally safe, with no significant changes in vital signs or major side effects, although 60% of participants experienced weight gain, indicating the need for further research to confirm its efficacy and safety in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential effectiveness and safety of olanzapine in refractory panic disorder. Hollifield, M., Thompson, PM., Ruiz, JE., et al.[2022]

In a study of 135 patients with panic disorder, moclobemide (450 mg/day) was found to be as effective as clomipramine (150 mg/day) after 8 weeks, with similar rates of treatment response (49% for moclobemide vs. 53% for clomipramine).

Moclobemide had a better safety profile, with fewer adverse effects compared to clomipramine, which had higher rates of anticholinergic side effects; common side effects for moclobemide included headache and dizziness, but were generally infrequent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of moclobemide compared to clomipramine in the treatment of panic disorder. Krüger, MB., Dahl, AA.[2022]

Despite SSRIs and CBT being effective first-line treatments for panic disorder, treatment resistance is common due to factors like inadequate trial duration and poor tolerability.

For patients who do not respond to SSRIs, alternative strategies include combining treatments with benzodiazepines or TCAs, using newer antidepressants like venlafaxine XR, or exploring CBT, which shows preliminary efficacy in medication-resistant cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of treatment-refractory panic disorder. Mathew, SJ., Coplan, JD., Gorman, JM.[2022]

Citations

1.

abbvieclinicaltrials.com

abbvieclinicaltrials.com/study/?id=CVL-865-PA-2001

A Study to Evaluate Efficacy, Safety, and Tolerability of ...

The purpose of this trial is to measure the efficacy, safety, and tolerability of darigabat (25 milligrams \[mg\] twice daily \[BID\]) compared with placebo ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05941442

NCT05941442 | A Study to Evaluate Efficacy, Safety, and ...

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 ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04592536

NCT04592536 | A Trial of the Effect of CVL-865 on Panic ...

Participants will rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item is scored by ...

4.

news.abbvie.com

news.abbvie.com/2022-02-15-Cerevel-Therapeutics-Announces-Positive-Topline-Results-for-Darigabat-in-Phase-1-Clinical-Trial-in-Acute-Anxiety

Cerevel Therapeutics Announces Positive Topline Results ...

Both the 7.5 mg and 25 mg twice-daily doses of darigabat demonstrated a clinically meaningful and statistically significant improvement in the Panic Symptoms ...

5.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000202097

Phase 1 Trial of Darigabat for the Reduction of Acute ...

Objective:To evaluate the panicolytic effect of 2 dose strengths of darigabat in reducing panic and fear symptoms following carbon dioxide (CO2) inhalation ...

6.

go.drugbank.com

go.drugbank.com/drugs/DB18966

Darigabat: Uses, Interactions, Mechanism of Action

... Safety, and Tolerability of Darigabat in Participants With Panic Disorder ... outcomes with our structured adverse effects data. See a ...