Panic Disorder
Conditions
Keywords
panic, mental illness
Brief summary
The purpose of this study is to determine the safety and efficacy of potential new treatment called HB-1 versus placebo in male and female adult patients aged 18 to 60 years, inclusive, with panic disorder.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled trial. All patients with panic disorder, with or without specified co-morbidities, who meet all of the inclusion and none of the exclusion criteria will be eligible. Patients and researchers will be blinded to their treatment group. The study will enroll approximately 80 adult patients who meet the diagnosis of panic disorder. The patients will be treated for 12 weeks including a 1 week safety follow up visit following the last dose of study drug.
Interventions
DRUGHB-01
HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
DRUGPlacebo
HB-1 matched placebo
Sponsors
Cognitive Research Corporation
Honeybrains Biotech LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
An unblinded pharmacist will be utilized to assign bottles to each patient using an Interactive Voice Response System (IVRS) central randomization system. Study treatment or placebo will be dispensed to patients in blinded bottles.
Intervention model description
A sample size of 80 patients is planned for the study to be randomized in a 1:1 ratio of active to control.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria 1. Male or female aged 18 to 60 years old, inclusive, at the time of informed consent. 2. Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Criteria for Panic Disorder. 3. Documented moderate to severe levels of symptoms at baseline (Panic Disorder Severity Scale of 13 or above) 4. Medically stable on current medication regimen for at least 3 months including PRN ('as needed') medications as determined by Investigator. 5. Willing to remain on current doses of other psychiatric medications throughout the length of the trial (unless a dose reduction is warranted due to improvement in symptoms). 6. Willing and able to safely stop any of the following medications prior to study trial: Inhibitors or inducers of CYP3A4 (erythromycin, ritonavir, telithromycin, rifampin), HMG-CoA (hydroxy methylglutaric acid coagulase) Reductase Inhibitors (Simvastatin, Lovastatin, Atorvastatin), Beta Blockers (Timolol eyedrops, Metoprolol), Neuromuscular Blocking Agents (curare-like and depolarizing), Antihypertensive Agents (Prazosin and vasodilators, angiotensin-converting enzyme inhibitors, diuretics, beta blockers), Inhalation Anesthetics, Disopyramide, Flecainide, Quinidine, Cimetidine, Lithium, Carbamazepine, Phenobarbital, Cyclosporine, Digitalis, Aliskiren, Ramipril and Ramiprilat, aspirin. 7. Fluent in English. 8. Willing to take HB-1 or placebo. 9. Willing and able to provide informed consent indicating an understanding of the requirements of the study and a willingness to comply with scheduled visits and all study procedures. 10. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be least 2 years postmenopausal or commits to use 2 acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment. Individuals who are involved exclusively in same-sex relationships are exempt from the birth control requirements but must agree to abide by the recommendations if they do engage in a heterosexual relationship. 11. Female patients who are women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening, within 7 days of dosing with study treatment. *
Exclusion criteria
1. Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to uncontrolled hypertension, hypotension (defined as below 90/60); unstable angina; myocardial infarction (MI) or cerebrovascular accident (CVA). 2. Any clinically significant electrocardiogram (ECG) abnormalities at screening. 3. Inadequate hepatic function defined as total bilirubin \>1.5 × the upper limit of normal (ULN) ranges of each institution, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>3 × the ULN range of each institution. 4. Inadequate renal function defined as serum creatinine \>1.5 × the ULN range of each institution and/or estimated glomerular filtration rate (eGFR) \<60. 5. Any clinically significant abnormalities in clinical laboratory assessments as assessed by the Investigator. 6. Any other systemic conditions or organ abnormalities that in the opinion of the Investigator may interfere with the conduct and/or interpretation of the current study. 7. Unable to complete neuropsychological testing. 8. Diagnosis of Bipolar I, Bipolar II disorder or Schizophrenia. 9. History of suicidal behaviors including ideation. 10. Current treatment with doses of benzodiazepines that are outside the FDA-approved prescriber's information. 11. Already on treatment with either telmisartan or verapamil or both. 12. Documented prior drug allergy to either telmisartan or verapamil. 13. Documented contraindication to taking telmisartan or verapamil: (eg, Duchenne's muscular dystrophy, myasthenia gravis). 14. Documented moderate to severe substance abuse within the last 6 months (recreational cannabis use is allowed). 15. Pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Up to 12 weeks | Safety was evaluated through Adverse Event monitoring, review of clinically significant changes in routine laboratory tests, ECGs, and orthostatic vital signs. The safety results were presented as: number of subjects reporting an adverse event as percentage of study population that met the eligibility criteria. |
| Change in Panic Disorder Symptom Severity Scale (PDSS) | Up to 12 weeks | Percentage of patients who achieved panic free status after 12 weeks |
| Change in Clinical Global Impression-Severity Scale (CGI-S) | Up to 12 weeks | CGI-S is a 7 point scale where 1 indicates normal, not at all ill and 7 indicates amongst the most extremely ill patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Panic Attacks | Up to 12 weeks | The proportion of all subjects achieving panic-free status at the end of the study. |
Countries
United States
Participant flow
Pre-assignment details
Three participants withdrew prior to receiving study treatment changing 86 to 83 subjects treated.
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment (HB-01) 44 patients received HB-01 active study drug.
HB-01: HB-1 will be supplied as a dual active pharmaceutical ingredient tablet. | 42 |
| Placebo Treatment Approximately 42 patients received matched placebo.
Placebo: HB-1 matched placebo | 41 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo Treatment | Total | Active Treatment (HB-01) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 83 Participants | 42 Participants |
| Age, Continuous | 36.3 years STANDARD_DEVIATION 13.54 | 37.3 years STANDARD_DEVIATION 11.96 | 38.4 years STANDARD_DEVIATION 10.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 21 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 25 Participants | 51 Participants | 26 Participants |
| Region of Enrollment United States | 41 Participants | 83 Participants | 42 Participants |
| Sex: Female, Male Female | 30 Participants | 61 Participants | 31 Participants |
| Sex: Female, Male Male | 11 Participants | 22 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 41 |
| other Total, other adverse events | 23 / 42 | 15 / 41 |
| serious Total, serious adverse events | 0 / 42 | 0 / 41 |
Outcome results
Primary
Change in Clinical Global Impression-Severity Scale (CGI-S)
CGI-S is a 7 point scale where 1 indicates normal, not at all ill and 7 indicates amongst the most extremely ill patients.
Time frame: Up to 12 weeks
Population: 3 subjects withdrew before dosing: only 83 treated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment (HB-01) | Change in Clinical Global Impression-Severity Scale (CGI-S) | 2.95 score on a scale | Standard Deviation 1.053 |
| Placebo Treatment | Change in Clinical Global Impression-Severity Scale (CGI-S) | 3.33 score on a scale | — |
Primary
Change in Panic Disorder Symptom Severity Scale (PDSS)
Percentage of patients who achieved panic free status after 12 weeks
Time frame: Up to 12 weeks
Population: Panic Disorder Severity Scale Score (PDSS) Change from Baseline (ITT Population)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment (HB-01) | Change in Panic Disorder Symptom Severity Scale (PDSS) | 35 Participants |
| Placebo Treatment | Change in Panic Disorder Symptom Severity Scale (PDSS) | 35 Participants |
Primary
Incidence of Treatment-Emergent Adverse Events
Safety was evaluated through Adverse Event monitoring, review of clinically significant changes in routine laboratory tests, ECGs, and orthostatic vital signs. The safety results were presented as: number of subjects reporting an adverse event as percentage of study population that met the eligibility criteria.
Time frame: Up to 12 weeks
Population: Safety Population - subjects who were randomized and received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment (HB-01) | Incidence of Treatment-Emergent Adverse Events | 23 Participants |
| Placebo Treatment | Incidence of Treatment-Emergent Adverse Events | 15 Participants |
Secondary
Number of Panic Attacks
The proportion of all subjects achieving panic-free status at the end of the study.
Time frame: Up to 12 weeks
Population: Panic Frequency in the Entire ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment (HB-01) | Number of Panic Attacks | 17 Participants |
| Placebo Treatment | Number of Panic Attacks | 10 Participants |