Headache hope: daily drug may cut tension headaches in half
NCT ID NCT07359248
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the antidepressant venlafaxine can reduce how often and how severe tension-type headaches are in people who get them frequently. About 432 adults aged 18-65 with 6-14 headache days per month will take the drug for 12 weeks. Researchers will track headache days and overall headache burden to see if preventive treatment helps.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 432 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
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Other studies related to the condition(s) this trial covers.
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