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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
Active trigeminal nerve stimulation
Sham trigeminal nerve stimulation
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Response
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.
Time frame: Clinical Global Impression - Improvement scale (CGI-I) will be administered after 8 weeks of treatment.
Remission
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.
Time frame: Clinical Global Impression - Severity scale (CGI-S) will be administered after 8 weeks of treatment.
Generalized anxiety disorder symptoms
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).
Time frame: Generalized Anxiety Disorder 7-item scale (GAD-7) will be administered after 8 weeks of treatment.
Social anxiety disorder symptoms
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).
Time frame: Social Phobia Inventory (SPIN) will be administered after 8 weeks of treatment.
Panic disorder symptoms
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).
Time frame: Panic Disorder Severity Scale - Self Report version (PDSS-SR) will be administered after 8 weeks of treatment.
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Functioning
Improvement of functioning measured with the Sheehan Disability Scale (SDS). Scores go from 0 (no functional impairment) to 10 (severe functional impairment).
Time frame: Sheehan Disability Scale (SDS) will be administered after 8 weeks of treatment.
Sustained response
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.
Time frame: Clinical Global Impression - Improvement scale (CGI-I) will be administered two weeks after the end of the treatment.
Sustained remission
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.
Time frame: Clinical Global Impression - Severity scale (CGI-S) will be administered two weeks after the end of the treatment.