Generalized Anxiety Disorder
Conditions
Brief summary
This is a feasibility study for trigeminal nerve stimulation (TNS) in patients with treatment-resistant generalized anxiety disorder (TR-GAD). Ten participants will receive TNS for 8 weeks as an augmentation strategy to pharmacological treatment for generalized anxiety disorder (GAD). * The primary objective is to ascertain if TNS is a safe and well-tolerated treatment for patients with TR-GAD. * The secondary objective will be to monitor changes in GAD symptom severity throughout the study. Results from this study will inform a randomized controlled trial to be conducted in the future.
Interventions
Active trigeminal nerve stimulation
Sponsors
Dr. Rafael Freire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a traditional feasibility study, which evaluates preliminary safety and effectiveness information. It does not meet the definition of a device feasibility study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) criteria for generalized anxiety disorder. * Subjects on a stable dose of an selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) for at least 8 weeks. * Treatment-resistant - treatment resistance will be defined as lack of response to at least two drugs, from two different classes of drugs considered first-line or second-line for GAD. Only trials lasting at least 8 weeks, and with at least the minimum effective dose of the given medication will be considered failed trials.
Exclusion criteria
* Moderate to severe major depressive disorder * Moderate to high suicidality * Diagnosis of obsessive compulsive disorder (OCD), PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities and dementia or other neurological diseases including trigeminal neuralgia * Pregnant or breastfeeding women * Participants who are experiencing seizures * Implanted vagal nerve stimulation (VNS) or other electrical devices * Participants 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 |
|---|---|---|
| Incidence of treatment-emergent adverse events | Throughout the study, 8 weeks | Monitor participants for treatment-emergent adverse events and serious adverse events. |
| Incidence of treatment-emergent side effects measured with the NSEC | Baseline visit, 4-week visit and 8-week visit. | Monitor participants for minor treatment-emergent side effects measured with the Neurostimulation Side-Effect Checklist (NSEC). NSEC is a list of 31 possible side effects from neurostimulation or from antidepressants. Each item is rated from 0 (absent) to 3 (severe). |
| Response to treatment defined by CGI-I score below 3 | 4-week visit and 8-week visit. | Response to treatment, which will be defined as a score of 1 or 2 on the Clinical Global Impression - Improvement (CGI-I) scale. CGI-I is a clinician administered one-item clinical scale rated from 1 (very much improved) to 7 (very much worse). Not assessed would confer score 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of anxiety symptoms measured with PSWQ | Baseline visit, 4-week visit and 8-week visit. | Changes in scores for Penn State Worry Questionnaire (PSWQ) by comparing the scores in each visit. PSWQ is a self-rated 16-item scale, each item is rated from 1 (not at all typical of me) to 5 (very typical of me). |
| Remission defined by CGI-S score below 3 | 4-week visit and 8-week visit. | Remission will be defined as a score of 1 or 2 on the Clinical Global Impression - Severity (CGI-S) scale. CGI-S is a clinician administered one-item clinical scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Not assessed would confer score 0. |
| Change of anxiety symptoms measured with BAI | Baseline visit, 4-week visit and 8-week visit. | Changes in scores for Beck Anxiety Inventory (BAI) by comparing the scores in each visit. BAI is a self-rated 21-item scale, each item is rated from 0 (not at all) to 3 (severely - it bothered me a lot). |
| Change in anxiety severity measured by CGI-S | Baseline visit, 4-week visit and 8-week visit. | Changes in scores for CGI-S by comparing the scores in each visit. CGI-S is a clinician administered one-item clinical scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Not assessed would confer score 0. |
| Change of anxiety symptoms measured with GAD-7 | Baseline visit, 4-week visit and 8-week visit. | Changes in scores for Generalized Anxiety Disorder 7-item scale (GAD-7) by comparing the scores in each visit. GAD-7 is a self-rated 7-item scale, each item is rated from 0 (not at all) to 3 (nearly every day). |
Countries
Canada
Contacts
Primary ContactYan Deng
Backup ContactRafael Freire, MD PhD
Outcome results
None listed