Clinical trial NCT04931134: Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation
Official title: Trigeminal Nerve Stimulation in Anxiety Disorders: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Panic Disorder
Generalized Anxiety Disorder
Social Anxiety Disorder
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Response
timeFrame: Clinical Global Impression - Improvement scale (CGI-I) will be administered after 8 weeks of treatment.
measure: Remission
timeFrame: Clinical Global Impression - Severity scale (CGI-S) will be administered after 8 weeks of treatment.
Secondary outcomes:
measure: Generalized anxiety disorder symptoms
timeFrame: Generalized Anxiety Disorder 7-item scale (GAD-7) will be administered after 8 weeks of treatment.
measure: Social anxiety disorder symptoms
timeFrame: Social Phobia Inventory (SPIN) will be administered after 8 weeks of treatment.
measure: Panic disorder symptoms
timeFrame: Panic Disorder Severity Scale - Self Report version (PDSS-SR) will be administered after 8 weeks of treatment.
measure: Functioning
timeFrame: Sheehan Disability Scale (SDS) will be administered after 8 weeks of treatment.
measure: Sustained response
timeFrame: Clinical Global Impression - Improvement scale (CGI-I) will be administered two weeks after the end of the treatment.
measure: Sustained remission
timeFrame: Clinical Global Impression - Severity scale (CGI-S) will be administered two weeks after the end of the treatment.
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Department of Psychiatry, Queen's University
name: Rafael Freire, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: