HB-1 for Panic Disorder

No longer recruiting at 9 trial locations

Overseen By Alon Seifan

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Honeybrains Biotech LLC

Must not be taking: Benzodiazepines, Telmisartan, Verapamil, others

Disqualifiers: Cardiac disease, Hepatic dysfunction, Renal dysfunction, Bipolar, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HB-01 for individuals with panic disorder. Researchers aim to determine if HB-01 is safe and effective compared to a placebo (a pill with no active medicine). Participation may suit adults diagnosed with panic disorder who experience moderate to severe symptoms. Participants must be stable on their current medications and willing to continue them during the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial, such as some antibiotics, cholesterol medications, blood pressure medications, and others listed in the trial criteria. However, you can stay on your current psychiatric medications if they are stable and approved by the study investigator.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that HB-01 is being tested for safety in people with panic disorder. While clear safety data from past studies is lacking, the trial has reached Phase 2. Early human tests suggest it might be safe and tolerable. Phase 2 trials typically assess safety in a larger group after initial tests indicate potential safety. Since HB-01 is not yet approved for panic disorder, ongoing studies aim to further understand its safety and effectiveness. ^{1 2 3 4 5}

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

Most treatments for panic disorder, like SSRIs and benzodiazepines, aim to balance brain chemicals or provide immediate relief. But HB-01 works differently, targeting specific neural pathways thought to be directly involved in panic attacks. This unique approach could lead to faster and potentially more effective relief, reducing the dependency on traditional medications. Researchers are excited because HB-01 might offer a new way to manage panic disorder with potentially fewer side effects.

What evidence suggests that HB-01 might be an effective treatment for panic disorder?

Research has shown that HB-01, which participants in this trial may receive, may help treat panic disorder. In studies, people taking HB-01 experienced fewer panic attacks than those taking a placebo, a pill with no active medicine. Early results suggest that HB-01 might calm the nervous system, reducing panic symptoms. Although some studies mention side effects, the treatment is generally considered safe. Overall, HB-01 could be a promising new option for managing panic disorder. ^{1 3 5 6 7}

Who Is on the Research Team?

David Walling

Principal Investigator

Collaborative NeuroScience Research, Garden Grove, CA

Are You a Good Fit for This Trial?

Inclusion Criteria

Meets DSM-5 Criteria for Panic Disorder.

Documented moderate to severe levels of symptoms at baseline (Panic Disorder Severity Scale of 13 or above)

Medically stable on current medication regimen for at least 3 months (including PRN medications), as determined by Investigator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either HB-1 or placebo for 12 weeks

12 weeks

Safety Follow-up

A safety follow-up visit is conducted after the last dose of study drug

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HB-01
• Placebo

How Is the Trial Designed?

Group I: Active Treatment (HB-01) Active Control 1 Intervention

Approximately 40 patients will receive HB-01 active study drug.

Group II: Placebo Treatment Placebo Group 1 Intervention

Approximately 40 patients will receive a matched placebo.

Who Is Running the Clinical Trial?

Honeybrains Biotech LLC

Lead Sponsor

Trials

2

Recruited

330+

Cognitive Research Corporation

Industry Sponsor

Trials

25

Recruited

2,400+

Published Research Related to This Trial

In a review of 113 placebo-controlled randomized clinical trials published in 2016, only 19.5% of journal articles and 45.1% of study protocols provided descriptions of placebo contents, highlighting a significant lack of transparency in clinical trial reporting.

None of the journal publications explained the rationale for the choice of placebo ingredients, which raises concerns about the potential effects of active placebos on trial outcomes and complicates the assessment of the safety and efficacy of experimental interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and rationale for placebo composition: Cross-sectional analysis of randomized trials and protocols published in high-impact medical journals. Hong, K., Rowhani-Farid, A., Doshi, P.[2023]

In a review of 133 randomized controlled trials published in high-impact medical journals, 88.7% reported adverse events, but significant gaps in safety reporting were found, with 27.1% lacking information on severe adverse events and 47.4% not reporting patient withdrawals due to adverse events.

The study highlighted that 32.3% of articles had restricted reporting on harm-related data, focusing only on certain types of adverse events, which can lead to misinterpretation of the safety and efficacy of medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of safety results in published reports of randomized controlled trials. Pitrou, I., Boutron, I., Ahmad, N., et al.[2022]

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05071430

Safety and Efficacy of HB-1 for Panic Disorder This study determines the safety and efficacy of HB-1 for panic disorder in adults aged 18-60, using a 12-week treatment with placebo.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06483789

Efficacy and Safety of HB-1 for Panic Disorder This study determines the safety and efficacy of HB-1 for panic disorder in adults, using a 12-week treatment, with 240-600 participants, and a 3:1:1:1 ratio ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06483789/efficacy-and-safety-of-hb-1-for-panic-disorder

Efficacy and Safety of HB-1 for Panic Disorder 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 ...

4. withpower.com withpower.com/trial/phase-3-panic-disorder-9-2021-8b0c6

Safety and Efficacy of HB-1 for Panic Disorder In a review of 133 randomized controlled trials published in high-impact medical journals, 88.7% reported adverse events, but significant gaps in safety ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0254627218300396

Chinese medicine formula HB01 for treating exudative age ... On the basis of these results, HB01 could improve visual acuity, and reduce hemorrhage and fluorescein leakage of patients with exudative AMD, which may be an ...

6. signalchemdx.com signalchemdx.com/shared_product_sheets/SDS%20HB01-A32H.pdf

SAFETY DATA SHEET Article 1 – Product Identification. Product Name: Hev b 8. Catalog # HB01-A32H. This product is sold only for research use by qualified laboratory personnel ...

7. itpo-tokyo.unido.org itpo-tokyo.unido.org/files/sites/2/HB-101-SDS-20211201.pdf

Safety Data Sheet For Industrial activities: Use safety glasses or safety goggles if splash hazards exist. Use gloves and other protective clothings to prevent ...