Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy

NCT04818099 | Unknown Phase 3 DMC

• 1 other identifier: 20200813
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Injuries

Keywords

Vortioxetine; Depression; Cognitive function; Head and Neck Cancers

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)

  Baseline to Week 8

• Change from baseline to 8 weeks in Rey Auditory Verbal Learning Test (RAVLT)

  Baseline to Week 8

• Change From Baseline to Week 8 in the Trail Making Test (TMT-A)

  Baseline to Week 8

• Percentage of participants with MADRS response at week 8

  Baseline to Week 8

• Change from baseline to 8 weeks in the HAM-A (Hamilton Anxiety Rating Scale)

  Baseline to Week 8

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Vortioxetine 10 mg DRUG

Vortioxetine will be used with a dosage of 10mg once a day, for 2 months.

routine supportive psychotherapy and votioxetine

Placebo OTHER

Placebo will be used with a dosage of one tablet once a day for 2 months.

routine supportive psychotherapy and control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Sun Yat-sen University: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• Brain Hospital Affiliated to Guangzhou Medical University: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Radiation Injuries; Depression; Head and Neck Neoplasms

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Wounds and Injuries; Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yamei Tang

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yamei Tang, M.D.

CONTACT

+86 13556001002; yameitang@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 26, 2021
• Study Start: October 10, 2020
• Primary Completion: October 10, 2023
• Study Completion: April 1, 2024
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

CN (1)