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Active, not recruitingNCT07359248Updated Jan 22, 2026

Desvenlafaxine for Preventive Treatment of Frequent Episodic Tension-type Headache

An interventional study of Desvenlafaxine and Placebo in Tension Type Headache, sponsored by Tongji Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Tongji Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
432
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Tension Type Headache

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03

In context

Tension-Type Headache

144 studies on the registry are indexed under Tension-Type Headache; 41 are open to participants now.

This study's planned enrollment of 432 is above the median of 60 across 109 interventional studies indexed under Tension-Type Headache.

Browse Tension-Type Headache studies →

Lead sponsor

Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
432 participants (estimated)

Study arms

  • Experimental
    Desvenlafaxine

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

    Drug: Desvenlafaxine

  • Placebo comparator
    placebo

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

    Drug: Placebo

Interventions

  • DrugDesvenlafaxine

    Desvenlafaxine

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. 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)

    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)

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

Secondary outcomes

  1. Total headache index AUC (area under the curve) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

    Total headache index AUC (area under the curve) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

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

  2. Headache severity (VAS 0-10) and duration (hours per day) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

    Headache severity (VAS 0-10) and duration (hours per day) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

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

  3. Acute analgesic consumption: number of days and dosage

    Acute analgesic consumption: number of days and dosage

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

  4. Treatment effectiveness criterion: reduction in headache days by ≥50% during the third 4-week intervention period compared to the screening period

    Treatment effectiveness criterion: reduction in headache days by ≥50% during the third 4-week intervention period compared to the screening period

    Time frame: during the third 4-week intervention period

  5. Safety assessment and tolerability evaluation

    Safety and tolerability will be evaluated by: Continuous recording of treatment-emergent adverse events (TEAEs, graded by CTCAE v5.0) throughout the study.

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

  6. Change in headache impact on daily life as assessed by the 6-item Headache Impact Test (HIT-6) total score

    The HIT-6 questionnaire measures the adverse impact of headache on daily functioning in six domains (pain, social functioning, role functioning, vitality, cognitive functioning, psychological distress).

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

07

Study locations

1 site
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430000, China
08

References and documents

Individual participant data

Plan to share: No — No immediate plans exist for IPD sharing, but controlled access may be considered post-study completion

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07359248
Lead sponsor
Tongji Hospital
Responsible party
Wensheng Qu (Professor, Tongji Hospital) — Principal investigator
First posted
Jan 22, 2026
Start date
Dec 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Jan 22, 2026

Study contacts

Wensheng Qu
principal investigator · Tongji Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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