Active — Not RecruitingNot Applicable

Desvenlafaxine for Preventive Treatment of Frequent Episodic Tension-type Headache

China432 participantsStarted 2025-12-01

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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;

What they're measuring

Days with tension-type headache (TTH) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

Timeframe: During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

Trial details

NCT IDNCT07359248

SponsorTongji Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Tension Type Headache trials