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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
| Brain Hospital Affiliated to Guangzhou Medical University | UNKNOWN |
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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.
Head and neck cancer (HNC) is the fifth most common cancer in the world, especially in South China. The incidence of depression and anxiety in HNC patients after radiotherapy is as high as 12% - 45% due to appearance changes, decreased swallowing function, dry mouth, pain and other discomfort. At the same time, radiotherapy, as mainstay of therapy for HNC, also causes different degrees of damage to the brain around the tumor, leading to secondary cognitive dysfunction. Depression, anxiety and cognitive impairment seriously affect the quality of life of HNC patients after radiotherapy. Recent studies have found that votioxetine has multimodal pharmacodynamic activity, which can not only improve symptoms of depression, but also significantly improve the cognitive function of patients. In this study, investigators will discuss the therapeutic effect of vortioxetine on the depression after radiotherapy in HNC patients through a multi-center, randomized and double-blind comparative clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| routine supportive psychotherapy and votioxetine | Experimental | 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. |
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| routine supportive psychotherapy and control | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine 10 mg | Drug | Vortioxetine will be used with a dosage of 10mg once a day, for 2 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 8 in the MADRS Total Score | MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST) | The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Higher scores-correct number of symbols reflects greater objective cognitive functioning. | Baseline to Week 8 |
| Change from baseline to 8 weeks in Rey Auditory Verbal Learning Test (RAVLT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yamei Tang, M.D. | Contact | +86 13556001002 | yameitang@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yamei Tang | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D003863 | Depression |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Other | Placebo will be used with a dosage of one tablet once a day for 2 months. |
|
The purpose of the RAVLT is to assess verbal learning and memory. Specifically, it assesses immediate memory span, new learning, susceptibility to interference, and recognition memory. |
| Baseline to Week 8 |
| Change From Baseline to Week 8 in the Trail Making Test (TMT-A) | TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Lower scores represent better speed of processing. | Baseline to Week 8 |
| Percentage of participants with MADRS response at week 8 | MADRS response was defined as a ≥50% decrease in MADRS total score from baseline | Baseline to Week 8 |
| Change from baseline to 8 weeks in the HAM-A (Hamilton Anxiety Rating Scale) | HAM-A is a widely used and well-validated tool for measuring the severity of a patient's anxiety, Higher scores indicate greater severity of symptoms. | Baseline to Week 8 |
| Change in the quality of life | Change from baseline to 8 weeks and endpoint mean scores in FACT-H&N (the Functional Assessment of Cancer Therapy-Head and Neck) Scale，Higher scores indicate greater severity of symptoms. | Baseline to Week 8 |
| Change From Baseline to Week 8 in CGI-S (the Clinical Global Impressions-Severity) Score | The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). | Baseline to Week 8 |
| Dropouts due to adverse events | Number of participants who dropped out due to adverse events during the trial | Baseline to Week 8 |
| Dropouts due to inefficacy | Number of participants who dropped out due to inefficacy during the trial | Baseline to Week 8 |
| D009369 |
| Neoplasms |