Clinical trial · Interventional
Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy
A Multicenter, Randomized, Double-blind, Controlled Clinical Trial of Votioxetine in the Treatment of Depression After Radiotherapy for Head and Neck Cancer
NCT04818099CI-TRIAL-00050902unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effects of vortioxetine, once daily (QD), on mood disorders and cognitive dysfunction in patients with head and neck cancers undergoing radiotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Injuries | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Vortioxetine 10 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- routine supportive psychotherapy and votioxetine
- description
- On the basis of general psychotherapy, cognitive behavior therapy and supportive psychotherapy, the patients were given votioxetine 10mg/tablet, one tablet each time, once a day, for 2 months.
- interventionNames
- Drug: Vortioxetine 10 mg
- type
- PLACEBO_COMPARATOR
- label
- routine supportive psychotherapy and control
- description
- On the basis of general psychotherapy, cognitive behavior therapy and supportive psychotherapy, the patients were given placebo, one tablet each time, once a day, for 2 months.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Change From Baseline to Week 8 in the MADRS Total Score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * (1) Received radiation therapy due to head and neck cancer. * (2) The patient have depression symptoms (PHQ-9 score ≥ 8) and meet the ICD-10 (version 2019) diagnostic criteria. * (3) Age\>/= 18 years and age\</=65. * (4) Estimated life expectancy ≥ 12 months. * (5) Constant caregivers who well understand and have willingness to sign a written informed consent document. Exclusion Criteria: * (1) The researcher believe that the subjects have the tendency of suicide, self mutilation or the score of "suicide concept" in item 10 of MADRS was ≥5, or they had committed suicide, self mutilation within 6 months before enrollment; * (2) History of depressive disorder before radiotherapy for head and neck tumors; * (3) History of other serious mental disorders, such as generalized anxiety disorder, drug and alcohol abuse, etc; * (4) History of central nervous diseases such as Alzheimer's disease, Parkinson's disease, Stroke, uncontrolled epilepsy, etc., which lead to emotional and cognitive impairment and other serious and uncontrolled systemic diseases (such as cardiopulmonary insufficiency, etc.); * (5) Baseline Mini Mental State Examination (MMSE) score ≤ 23 points (University or above), MMSE ≤ 22 points (middle school), MMSE ≤ 20 points (primary school), MMSE ≤ 17 points (illiteracy); * (6) The subject with brain metastasis; * (7) Hematological examination of subject: White blood cell count \< 3.5×10\^9/L, Platelet count \< 100×10\^9/L, Hemoglobin \< 110g/L, Abnormal range of coagulation function like fibrinogen \< 1.5g/L, or other coagulation abnormalities with clinical significance; * (8) Blood biochemical examination of patients: Total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 2.0 x upper limit of normal value, Creatinine \> 1.5x upper limit of normal value, Blood sodium \< 130mmol/L; * (9) The subject has a history of severe drug allergy or is known to be allergic to any excipient of the test drug; * (10) The subjects who could not effectively complete the neuropsychological test during the follow-up.
References
Publications (0)
Data not yet available
No reference posted for this study.