Back to resultsVortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy
Primary Purpose
Radiation Injuries
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Vortioxetine 10 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Injuries focused on measuring Vortioxetine, Depression, Cognitive function, Head and Neck Cancers
Eligibility Criteria
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.
Sites / Locations
- Sun Yat-Sen Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
routine supportive psychotherapy and votioxetine
routine supportive psychotherapy and control
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Percentage of participants with MADRS response at week 8
MADRS response was defined as a ≥50% decrease in MADRS total score from baseline
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.
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.
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).
Dropouts due to adverse events
Number of participants who dropped out due to adverse events during the trial
Dropouts due to inefficacy
Number of participants who dropped out due to inefficacy during the trial
Full Information
NCT ID
NCT04818099
First Posted
March 22, 2021
Last Updated
March 25, 2021
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Sun Yat-sen University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Brain Hospital Affiliated to Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04818099
Brief Title
Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy
Official Title
A Multicenter, Randomized, Double-blind, Controlled Clinical Trial of Votioxetine in the Treatment of Depression After Radiotherapy for Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Sun Yat-sen University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Brain Hospital Affiliated to Guangzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Injuries
Keywords
Vortioxetine, Depression, Cognitive function, Head and Neck Cancers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
routine supportive psychotherapy and votioxetine
Arm Type
Experimental
Arm 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.
Arm Title
routine supportive psychotherapy and control
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Vortioxetine 10 mg
Intervention Description
Vortioxetine will be used with a dosage of 10mg once a day, for 2 months.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be used with a dosage of one tablet once a day for 2 months.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 8 in the MADRS Total Score
Description
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.
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)
Description
The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Higher scores-correct number of symbols reflects greater objective cognitive functioning.
Time Frame
Baseline to Week 8
Title
Change from baseline to 8 weeks in Rey Auditory Verbal Learning Test (RAVLT)
Description
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.
Time Frame
Baseline to Week 8
Title
Change From Baseline to Week 8 in the Trail Making Test (TMT-A)
Description
TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Lower scores represent better speed of processing.
Time Frame
Baseline to Week 8
Title
Percentage of participants with MADRS response at week 8
Description
MADRS response was defined as a ≥50% decrease in MADRS total score from baseline
Time Frame
Baseline to Week 8
Title
Change from baseline to 8 weeks in the HAM-A (Hamilton Anxiety Rating Scale)
Description
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.
Time Frame
Baseline to Week 8
Title
Change in the quality of life
Description
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.
Time Frame
Baseline to Week 8
Title
Change From Baseline to Week 8 in CGI-S (the Clinical Global Impressions-Severity) Score
Description
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).
Time Frame
Baseline to Week 8
Title
Dropouts due to adverse events
Description
Number of participants who dropped out due to adverse events during the trial
Time Frame
Baseline to Week 8
Title
Dropouts due to inefficacy
Description
Number of participants who dropped out due to inefficacy during the trial
Time Frame
Baseline to Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yamei Tang, M.D.
Phone
+86 13556001002
Email
yameitang@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yamei Tang
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamei Tang, M.D.
Phone
+86 13556001992
Email
yameitang@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy
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