Desvenlafaxine for Preventive Treatment of Frequent Episodic Tension-type Headache

Study on the Effectiveness of Preventive Treatment With Venlafaxine for Frequent Episodic Tension-type Headache

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

Study Overview

• Status: Active, not recruiting
• Conditions: Tension Type Headache
• Intervention / Treatment: Drug: Placebo; Drug: Desvenlafaxine

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.

• Study Type: Interventional
• Enrollment (Estimated): 432
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desvenlafaxine; Participants in this arm will receive oral Desvenlafaxine at a fixed dose of 50 mg once daily for 12 weeks.	Drug: Desvenlafaxine; Desvenlafaxine
Placebo Comparator: placebo; Participants in this arm will receive an identical-appearing placebo tablet administered orally once daily for 12 weeks.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Acute analgesic consumption: number of days and dosage	Acute analgesic consumption: number of days and dosage	during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
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	during the third 4-week intervention period
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.	During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
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).	During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Wensheng Qu, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Tension-Type Headache; Organic Chemicals; Lipids; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Alcohols; Cyclohexanols; Hexanols; Fatty Alcohols; Desvenlafaxine Succinate
• Other Study ID Numbers: 20251111TTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No immediate plans exist for IPD sharing, but controlled access may be considered post-study completion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No