Trigeminal Nerve Stimulation in Anxiety Disorders: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Remission
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sham stimulation
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM5 criteria for panic disorder, social anxiety disorder or generalized anxiety disorder.
排除标准
- •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.
结局指标
主要结局
Remission
时间窗: 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.
Response
时间窗: 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.
次要结局
- Sustained remission(Clinical Global Impression - Severity scale (CGI-S) will be administered two weeks after the end of the treatment.)
- Social anxiety disorder symptoms(Social Phobia Inventory (SPIN) will be administered after 8 weeks of treatment.)
- Panic disorder symptoms(Panic Disorder Severity Scale - Self Report version (PDSS-SR) will be administered after 8 weeks of treatment.)
- Sustained response(Clinical Global Impression - Improvement scale (CGI-I) will be administered two weeks after the end of the treatment.)
- Generalized anxiety disorder symptoms(Generalized Anxiety Disorder 7-item scale (GAD-7) will be administered after 8 weeks of treatment.)
- Functioning(Sheehan Disability Scale (SDS) will be administered after 8 weeks of treatment.)
研究者
Dr. Rafael Freire
Associate Professor, Department of Psychiatry
Kingston Health Sciences Centre