Desvenlafaxine for Preventive Treatment of Frequent Episodic Tension-type Headache

Tongji Hospital

Status: Active, not recruiting

Conditions: Tension Type Headache

Treatments: Drug: Placebo; Drug: Desvenlafaxine

Study type: Interventional

Funder types: Other

Identifiers

NCT07359248

20251111TTH

Details and patient eligibility

About

To evaluate whether Desvenlafaxine can reduce the frequency and severity of TTH attacks in patients.

Full description

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.

Enrollment: 432 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects aged 18-65 years
2. 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
3. Informed consent obtained from the patient

Exclusion criteria

1. 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);
2. Diagnosable with chronic tension-type headache or medication overuse headache;
3. 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);
4. 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;
5. 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;
6. Alcohol dependence or substance abuse;
7. 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;
8. Women who are planning pregnancy, pregnant, breastfeeding, or not using contraception;
9. Participation in other interventional clinical studies that may influence outcome evaluations.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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432 participants in 2 patient groups, including a placebo group

Desvenlafaxine

Experimental group

Description:

Participants in this arm will receive oral Desvenlafaxine at a fixed dose of 50 mg once daily for 12 weeks.

Treatment:

Drug: Desvenlafaxine

placebo

Placebo Comparator group

Description:

Participants in this arm will receive an identical-appearing placebo tablet administered orally once daily for 12 weeks.

Treatment:

Drug: Placebo