N/A
Completed N=69
Using the Canary Breathing System for Panic Disorder Patients
Source: ClinicalTrials.gov NCT01955954 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response) — 33 Participants
Summary
The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS) in treating the symptoms of panic disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response) |
27 | — |
| SECONDARY Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response) |
27 | — |
| SECONDARY Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week |
26 | — |
Eligibility Criteria
Inclusion Criteria
- Primary diagnosis of Panic Disorder
- Subjects between 18 and 60 years of age (inclusive on day of enrollment)
- Subjects with a Clinician's Global Impression of > or = to 4.
- If on psychotropic medication, on a stable dose for a minimum of 3 months prior to enrollment
- If on psychotropic medication, an agreement to stay on their stable dose from study entry until the 2-month follow-up.
Exclusion Criteria
- Pregnancy
- Current enrollment in another drug or device study
- Current enrollment in another drug or device study that is not at least 30 days past the final follow-up
- Currently undergoing cognitive behavioral therapy (or equivalent)
- Refractory to either a breathing training program or cognitive behavioral therapy (or equivalent) in the 3 months prior to enrollment
- Evidence of organic mental disorder
- Severe suicidality
- Presence of any psychotic disorder
- Bipolar disorder that is present for < 5 years; a major depressive, manic or hypomanic episode in the last 12 months; failure to take and maintain a stable dose of medication in treatment of bipolar disorder in the last 12 months
- Current alcohol or drug dependence
- Cardiovascular or pulmonary disease
- Epilepsy or seizures
- Undergoing additional psychologic treatment at any point from study enrollment to 2-month follow-up to treat panic disorder
Data sourced from ClinicalTrials.gov (NCT01955954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.