Safety and Efficacy of HB-1 for Panic Disorder

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

86 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called HB-1 to see if it helps adults aged 18 to 60 who have panic disorder. The study will determine its safety and effectiveness. About 80 patients will participate, and they will be treated for a few months.

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 the treatment generally safe for humans?

The research highlights that placebo treatments, often used as controls in trials, can sometimes have active effects, which complicates understanding the safety of the actual treatment being tested. This means that without clear descriptions of what the placebo contains, it's hard to determine the true safety of the treatment. ^{1 2 3 4 5}

Research Team

David Walling

Principal Investigator

Collaborative NeuroScience Research, Garden Grove, CA

Eligibility Criteria

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

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

Treatment Details

Interventions

• HB-01
• Placebo

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Does maintained spinal manipulation therapy for chronic nonspecific low back pain result in better long-term outcome? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Reporting of safety results in published reports of randomized controlled trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]