Trigeminal nerve stimulation for treatment-resistant anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study investigates the use of trigeminal nerve stimulation (TNS) as an additional treatment for patients with treatment-resistant generalized anxiety disorder (TR-GAD). Over the course of 8 weeks, ten participants will receive TNS while continuing their pharmacological treatment. The primary goal is to evaluate the safety and tolerability of TNS, while secondary objectives include monitoring changes in anxiety symptom severity. The findings will help inform future randomized controlled trials.

Why it matters

Who can join: the full rules

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

Where it's running

• Kingston Health Sciences Centre
  Kingston, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Rafael Freire, MD PhD — Department of Psychiatry, Queen's University
• Study coordinator: Yan Deng
• Email: yan.deng@queensu.ca
• Phone: +1 613-548-7839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adjunctive JNJ-99245354 for Generalized Anxiety Disorder (GAD)

  This study tests whether adding JNJ-99245354 to existing GAD treatment helps reduce anxiety more than a placebo for adults with GAD who didn’t get adequate benefit from previous treatments.

  Recruiting at 4 sites Phase 3 Intra-Cellular Therapies, Inc. · Temecula, California and 3 other locations · NCT07856420

• Testing ITI-1284 for Generalized Anxiety Disorder (GAD)

  This phase 3 trial tests whether ITI-1284 is safe and tolerable when taken alone or with other medicines by adults with generalized anxiety disorder who haven’t responded to prior treatment.

  Recruiting at 3 sites Phase 3 Intra-Cellular Therapies, Inc. · Los Angeles, California and 2 other locations · NCT07807865

• Long-term safety and tolerability of SEP-363856 in adults with generalized anxiety disorder

  In adults with generalized anxiety disorder, this Phase 3 open-label extension tests whether continuing SEP-363856 at 50 mg or 75 mg daily for 26 weeks is safe, tolerable, and possibly helpful.

  Recruiting at 2 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Jacksonville, Florida and 1 other locations · NCT07786454

• Anxiety Skills Study: See if video skill training plus therapy helps people with anxiety

  This study tests whether a brief video-based skill training can help people with anxiety as well as four therapy sessions, and how durable the effects are over a year.

  Recruiting Ohio State University · Columbus, Ohio · NCT07774481

• Continuous Theta Burst Stimulation for Generalized Anxiety Disorder (cTBS for GAD)

  This study tests whether applying continuous theta burst stimulation to the right posterior parietal cortex or the right dorsolateral prefrontal cortex helps adults with generalized anxiety disorder.

  Recruiting Military Hospital 175 · Ho Chi Minh City · NCT07770919

• Fixed-dose SEP-363856 vs placebo for adults with generalized anxiety disorder

  This trial tests whether a fixed 75 mg/day dose of SEP-363856 helps adults with generalized anxiety disorder more than placebo over 8 weeks.

  Recruiting at 11 sites Phase 3 Otsuka Pharmaceutical Development & Commercialization, Inc. · Redlands, California and 10 other locations · NCT07767903

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.