Radiation InjuriesPhase 3NCT04818099
Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy
A Phase 3 study testing Vortioxetine 10 mg in people with Radiation Injuries, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiation Injuries
- What is being tested?
- Vortioxetine 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2020to 1 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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;
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- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510120
Yamei Tang, M.D., +86 13556001992, yameitang@hotmail.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial of Votioxetine in the Treatment of Depression After Radiotherapy for Head and Neck Cancer
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.
Read the detailed description
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.
- Conditions
- Radiation Injuries
- Being tested
- Vortioxetine 10 mg, Placebo
- Keywords
- Vortioxetine, Depression, Cognitive function, Head and Neck Cancers
- Medical subject headings
- Radiation Injuries, Depression, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vortioxetine 10 mgDrug
Vortioxetine will be used with a dosage of 10mg once a day, for 2 months.
PlaceboOther
Placebo will be used with a dosage of one tablet once a day for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vortioxetine 10 mg |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8
Secondary outcomes (9)
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.
Measured: Baseline to Week 8
Change from baseline to 8 weeks in Rey Auditory Verbal Learning Test (RAVLT)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline to Week 8
Dropouts due to adverse events
Number of participants who dropped out due to adverse events during the trial
Measured: Baseline to Week 8
Dropouts due to inefficacy
Number of participants who dropped out due to inefficacy during the trial
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start10 Oct 2020
- Primary completion10 Oct 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation InjuriesStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou Mental Hospital
- Responsible party
- Principal investigator, Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Yamei Tang, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818099
- Sponsor's protocol ID
- 20200813
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Controlled Clinical Trial of Votioxetine in the Treatment of Depression After Radiotherapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04818099
- Acronym / sponsor ID
- 20200813
- Conditions
- Radiation Injuries
- Keywords
- Vortioxetine, Depression, Cognitive function, Head and Neck Cancers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou Mental Hospital
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine supportive psychotherapy and votioxetine | Experimental | Drug: Vortioxetine 10 mgOn 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. |
| routine supportive psychotherapy and control | Placebo comparator | Other: PlaceboOn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (10 listed)
- (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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vortioxetine 10 mgVortioxetine will be used with a dosage of 10mg once a day, for 2 months. | Drug | routine supportive psychotherapy and votioxetine |
| PlaceboPlacebo will be used with a dosage of one tablet once a day for 2 months. | Other | routine supportive psychotherapy and control |
Primary outcome
Change From Baseline to Week 8 in the MADRS Total Score
Time frame: Baseline to Week 8
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.
9 secondary outcomes
Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)
Time frame: Baseline to Week 8
Change from baseline to 8 weeks in Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in the Trail Making Test (TMT-A)
Time frame: Baseline to Week 8
Percentage of participants with MADRS response at week 8
Time frame: Baseline to Week 8
Change from baseline to 8 weeks in the HAM-A (Hamilton Anxiety Rating Scale)
Time frame: Baseline to Week 8
Change in the quality of life
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in CGI-S (the Clinical Global Impressions-Severity) Score
Time frame: Baseline to Week 8
Dropouts due to adverse events
Time frame: Baseline to Week 8
Dropouts due to inefficacy
Time frame: Baseline to Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yamei Tang principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vortioxetine 10 mg in people with Radiation Injuries, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yamei Tang, M.D. (+86 13556001002, yameitang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 8 in the MADRS Total Score (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.