Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder
Conditions
Brief summary
Primary objectives: The primary objective is to ascertain if trigeminal nerve stimulation is an effective treatment with high tolerability for patients with panic disorder, generalized anxiety disorder and social anxiety disorder.
Interventions
DEVICETrigeminal nerve stimulation - active
Active trigeminal nerve stimulation
DEVICETrigeminal nerve stimulation - sham
Sham trigeminal nerve stimulation
Sponsors
Dr. Rafael Freire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sham stimulation
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meet DSM5 criteria for panic disorder, social anxiety disorder or generalized anxiety disorder.
Exclusion criteria
* Subjects undergoing cognitive behavioural therapy. * Subjects undergoing pharmacological treatment for an anxiety disorder. * Subjects undergoing pharmacological treatment with antidepressants or benzodiazepines. * Subjects with moderate to severe major depressive disorder based on the PHQ-9 test (score of 15 or above) at baseline. * Moderate to high current suicidality or suicide likely in near future or current suicidal behavior disorder. * Concurrent diagnosis of OCD, PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities or dementia. * Subjects diagnosed with neurological diseases including trigeminal neuralgia. * Pregnant or breastfeeding women. * Subjects who are experiencing seizures. * Individuals with implanted VNS or other electrical devices. * Subjects who are already undergoing transcutaneous electrical nerve stimulation. * Consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week. * Consumption of natural health products that may affect anxiety or depression symptoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response | Clinical Global Impression - Improvement scale (CGI-I) will be administered after 8 weeks of treatment. | Treatment response will be defined as a score of 1 or 2 on the Clinical Global Impression - Improvement scale (CGI-I). CGI-I scores range from 0 to 7. Zero corresponds to not assessed. Low scores correspond to improvement, high scores correspond to worsening. |
| Remission | Clinical Global Impression - Severity scale (CGI-S) will be administered after 8 weeks of treatment. | Remission will be defined as a score of 1 or 2 on the Clinical Global Impression - Severity scale (CGI-S). CGI-S scores range from 0 to 7. Zero corresponds to not assessed. Low scores correspond to mild and high scores correspond to severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Panic disorder symptoms | Panic Disorder Severity Scale - Self Report version (PDSS-SR) will be administered after 8 weeks of treatment. | Improvement of panic disorder symptoms measured with the Panic Disorder Severity Scale - Self Report version (PDSS-SR). Scores go from 0 (no panic symptoms) to 4 (severe panic symptoms). |
| Functioning | Sheehan Disability Scale (SDS) will be administered after 8 weeks of treatment. | Improvement of functioning measured with the Sheehan Disability Scale (SDS). Scores go from 0 (no functional impairment) to 10 (severe functional impairment). |
| Generalized anxiety disorder symptoms | Generalized Anxiety Disorder 7-item scale (GAD-7) will be administered after 8 weeks of treatment. | Improvement of generalized anxiety disorder symptoms measured with the Generalized Anxiety Disorder 7-item scale (GAD-7). Scores go from 0 (no generalized anxiety symptoms) to 21 (severe generalized anxiety symptoms). |
| Sustained remission | Clinical Global Impression - Severity scale (CGI-S) will be administered two weeks after the end of the treatment. | Remission will be defined as a score of 1 or 2 on the Clinical Global Impression - Severity scale (CGI-S). CGI-S scores range from 0 to 7. Zero corresponds to not assessed. Low scores correspond to mild and high scores correspond to severe. |
| Sustained response | Clinical Global Impression - Improvement scale (CGI-I) will be administered two weeks after the end of the treatment. | Treatment response will be defined as a score of 1 or 2 on the Clinical Global Impression - Improvement scale (CGI-I). CGI-I scores range from 0 to 7. Zero corresponds to not assessed. Low scores correspond to improvement, high scores correspond to worsening. |
| Social anxiety disorder symptoms | Social Phobia Inventory (SPIN) will be administered after 8 weeks of treatment. | Improvement of social anxiety disorder symptoms measured with the Social Phobia Inventory (SPIN). Scores go from 0 (no social anxiety symptoms) to 68 (severe social anxiety symptoms). |
Countries
Canada
Outcome results
None listed