NCT07359248进行中（未招募）不适用
Study on the Effectiveness of Preventive Treatment With Venlafaxine for Frequent Episodic Tension-type Headache
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 432
研究概览
简要总结
To evaluate whether Desvenlafaxine can reduce the frequency and severity of TTH attacks in patients.
详细描述
This randomized, double-blind, placebo-controlled trial aims to assess the efficacy of Desvenlafaxine (a serotonin-norepinephrine reuptake inhibitor) in reducing the frequency and severity of tension-type headache (TTH) attacks in adult patients with episodic TTH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects aged 18-65 years
- •Meeting the diagnostic criteria for tension-type headache (TTH) according to ICHD-3; with ≥6 but <15 attack days per month in the past 3 months and MIDAS score >21; onset of TTH before age 50, with a history exceeding 1 year
- •Informed consent obtained from the patient
排除标准
- •History of allergy to Desvenlafaxine, or use of Desvenlafaxine within 4 weeks prior to the start of the treatment period; currently taking or requiring concomitant administration of drugs contraindicated in the package insert, such as monoamine oxidase inhibitors (MAOIs);
- •Diagnosable with chronic tension-type headache or medication overuse headache;
- •Comorbid with other types of headaches, such as trigeminal autonomic cephalalgias, migraine attacks >1 time/month within 3 months, or secondary headaches (e.g., those caused by intracranial infections, craniocerebral trauma, cerebrovascular diseases);
- •Severe psychiatric disorders such as schizophrenia, moderate to severe anxiety-depression (Hamilton scale ≥12 points); poorly controlled epilepsy, cognitive impairments, and other chronic pain conditions; serious organic diseases that pose significant health risks, including uncontrolled hypertension, cardiac disease, hepatic dysfunction, renal insufficiency, infections; any medical condition or prior surgery likely to affect the absorption, metabolism, or excretion of the study drug;
- •Concomitant use of venlafaxine analogues such as serotonin-norepinephrine reuptake inhibitors (SNRIs); unstable use of other preventive medications for TTH, including amitriptyline, mirtazapine (≤3 months); discontinuation of currently reported effective prophylactic drugs or overused analgesics for ≥3 months may allow re-enrollment;
- •Alcohol dependence or substance abuse;
- •Inability to comprehend the study protocol due to low education level, impaired verbal/language function, visual or auditory deficits; failure to accurately complete research materials like headache diaries or cooperate with scale assessments;
- •Women who are planning pregnancy, pregnant, breastfeeding, or not using contraception;
- •Participation in other interventional clinical studies that may influence outcome evaluations.
研究者
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