RecruitingPhase 2NCT06483789

Efficacy and Safety of HB-1 for Panic Disorder

Efficacy and Safety of HB-1 for Panic Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Sponsor

HB BioTech, LLC

Enrollment

240 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Panic Disorder Mental Illness

Summary

The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo and two monotherapies, in male and female adult patients aged 18 to 65 years, inclusive, with Panic Disorder.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing HB-1, a new investigational medication, to see if it can reduce the frequency and severity of panic attacks in people with panic disorder. Panic disorder causes repeated, unexpected episodes of intense fear and physical symptoms like a racing heart, shortness of breath, and dizziness. **You may be eligible if...** - You are 18–65 years old - You have been diagnosed with panic disorder (DSM-V criteria) - You had at least one full, unexpected panic attack in the week before screening - Your current medications have been stable for at least 3 months - You are willing to stay on your current psychiatric medication doses throughout the study **You may NOT be eligible if...** - You are currently taking certain medications that interact with the study drug (including some antibiotics and grapefruit juice) - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - Your current treatment regimen is not stable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHB-1

HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.

DRUGTelmisartan Only Product in Oral Dose Form

Telmisartan will be supplied as a single active pharmaceutical ingredient tablet.

DRUGVerapamil Only Product in Oral Dose Form

Verapamil will be supplied as a single active pharmaceutical ingredient tablet.

DRUGPlacebo

Matched Placebo will be supplied as a tablet.

Locations(22)

Paratus Clinical Research Canberra

Canberra, Australian Capital Territory, Australia

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, Australia

East Sydney Doctors

Darlinghurst, New South Wales, Australia

Momentum Clinical Research Darlinghurst

Darlinghurst, New South Wales, Australia

Paratus Clinical Research Central Coast

Kanwal, New South Wales, Australia

Novatrials

Kotara, New South Wales, Australia

Canopy Clinical Sutherland

Miranda, New South Wales, Australia

Innovate Clinical Research

Waitara, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Canopy Clinical Wollongong

Wollongong, New South Wales, Australia

Paratus Clinical Research Brisbane

Herston, Queensland, Australia

Mackay Hospital and Health Service

Mackay, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

South Australian Health and Medical Research Institute

Adelaide, South Australia, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Grampians Health

Ballarat, Victoria, Australia

NeuroCentrix

Carlton, Victoria, Australia

Peninsula Therapeutic and Research Group

Frankston, Victoria, Australia

Multidisciplinary Alfred Psychiatry Research Clinic

Melbourne, Victoria, Australia

Ramsay Clinic Albert Road

Melbourne, Victoria, Australia

Paratus Clinical Research Melbourne

Northcote, Victoria, Australia

Clinitrials

Perth, Western Australia, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06483789

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Efficacy and Safety of HB-1 for Panic Disorder

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(22)

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