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Vortioxetine

Antidepressive Agents

Anti-Anxiety Agents

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Serotonin

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Serotonin 5-HT3 Receptor Antagonists

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.

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

Vortioxetine 10 mg

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

Placebo

Yamei Tang, M.D.

Yamei Tang

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.

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

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.

The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Higher scores-correct number of symbols reflects greater objective cognitive functioning.

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.

TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Lower scores represent better speed of processing.

MADRS response was defined as a ≥50% decrease in MADRS total score from baseline

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 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.

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).

Number of participants who dropped out due to adverse events during the trial

Number of participants who dropped out due to inefficacy during the trial

Sun Yat-sen University

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Brain Hospital Affiliated to Guangzhou Medical University

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

Professor

Depressive Disorder, Major

Mood Disorders

Mental Disorders

Psychotic Disorders

Quality of Life

Study participants will be started on a flexible-dose of vortioxetine (5-20 mg) followed by a baseline assessment of primary outcomes using the Montgomery-Asberg Depression Rating Scale (MADRS) and the Perceived Deficit Questionnaire - 5 items (PDQ-5), and secondary outcomes using the EORTC Quality of life Questionnaire (QLQ-C30) and Clinical Global Impression (CGI). The assessment timelines will be at week 2, week 4, week 8, and week 12.

Side effects, if any, will be recorded using the Antidepressant Side-effect Checklist (ASEC).

Flexible dosing from 5mg to 20mg based on attending psychiatrist's discretion

Chong Guan Ng

Sue-Yin Low

Tsui Huei Loo

Natasha Subhas

Chung Wah Lee

Muhammad Najib bin Abdullah

Kai Shin Thong

Sapini binti Yacob

Nik Ruzyanei Nik Jaafar

Nurul Ain binti Mohamad Kamal

Aya Ahmed Abousheishaa

Nor Zuraida Zainal

Azizul bin Awaluddin

The purpose of this observational antidepressant study is to determine the efficacy of vortioxetine on depression and cognitive function, and elucidate its potential effects on quality of life in patients with cancer (of any origin). We hypothesise that given its unique mechanism of action as a multimodal serotonin modulator, vortioxetine is set to achieve the above goals while maintaining a favourable side effect profile.

Cancer is always a feared illness and the diagnosis of cancer has huge psychological impact on the patients. Depression is one of the most common psychiatric sequelae and affects the disease outcome in cancer patients. Along with depression, cancer patients are also vulnerable to develop cognitive impairment. It could be related to the cancer or its treatment. Cognitive impairment that occurs among cancer patient is known as cancer related cognitive impairment (CRCI). Depression together with cognitive impairment adversely affect the quality of life of cancer patients. To date, the optimal treatment of depression in cancer is not established. The number of studies investigated the efficacy of pharmacotherapy for depression in cancer patient is limited. The evidence of treatment for cognitive impairment in depressed cancer patients is even more scarce.

Vortioxetine is one of the latest marketed antidepressants in Malaysia. It has numerous additional effects as compared to other conventional antidepressants. In addition to blockade of the serotonin transporter (SERT), vortioxetine has affinity for 5-HT1A, 5-HT1B, 5-HT3, and 5-HT7 receptors and as such, it is described as a 'multimodal serotonin modulator'. This may explain the additional benefit of vortioxetine in the treatment of depression as compared to other antidepressants. Furthermore, the unique mechanism of action of vortioxetine was also reported to improve cognitive function in patients with depression.

General Objective:

To examine the effect of vortioxetine in improving the depressive symptoms, cognitive impairment and quality of life in cancer patients who have major depressive disorder.

Specific Objectives:

1. To determine whether treatment with antidepressant vortioxetine is effective to improve depressive symptoms in patients diagnosed with cancer (of any origin) and major depressive disorder.
2. To determine whether treatment with antidepressant vortioxetine is effective to improve cognitive impairment in patients diagnosed with cancer (of any origin) and major depressive disorder.
3. To determine whether treatment with antidepressant vortioxetine is effective to improve quality of life in patients diagnosed with cancer (of any origin) and major depressive disorder.

Vortioxetine for Cancer Patients With Depression: An Observational Study

The MADRS is a widely used clinical rating scale for depression. It consists of 10 items evaluating core symptoms of depression (Montgomery \& Äsberg, 1979; Montgomery et al., 1978). Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe). The MADRS is relatively quick to administer and addresses core mood symptoms of depression such as sadness, tension, lassitude, pessimistic thoughts, and suicidal thoughts.

The PDQ-5 is a brief patient-rated scale to assess subjective cognitive dysfunction in people with depression. The PDQ originally is a 20-item questionnaire developed by Dr. Michael Sullivan at McGill University as a scale for use in patients with multiple sclerosis that generates a total score and 4 subscale scores (attention/concentration, retrospective memory, prospective memory, and planning/organization) (Sullivan et al., 1990). A 5-item version (PDQ-D-5) is a brief version and has been adapted and validated for use in patients with major depressive disorder.

The CGI allows psychiatrist to assess the patient's condition relative to baseline and rate the change on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).

The EORTC QLQ-C30 is widely used clinical scale for measurement of cancer-specific quality of life. It contains five functioning scales (physical, social, role, cognitive, and emotional functioning), eight symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, and diarrhea), financial impact, and overall quality of life. All scale scores are linearly converted to range from 0 to 100. For the functioning scales and global QOL higher scores indicate better functioning; for the symptom scales higher scores indicate higher symptom burden (Aaronson et al., 1993).

University of Malaya

Associate Professor

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Disease Progression

Breast Diseases

Skin Diseases

In cycle I of the study, participants will be randomized on to flexible-dose VTX (10-20 mg) versus. Vortioxetine starting dose will be 10 mg daily. Vortioxetine starting dose will be 10 mg daily with a dose escalation up to 20 mg daily at week #4. Study cycle II is an 8-week, open label treatment design for non-responders completing the Cycle I RCT. One treatment arm will continue VTX non-responders to 8 week VTX (10-20 mg/day) augmentation with cognitive behavioral therapy (10 sessions). The 2nd treatment arm will continue placebo non-responders who complete the RCT to VTX (10 to 20 mg/day). The third treatment arm will continue VTX responders/remitters who complete the RCT to open-label VTX for another 8-weeks to assess maintenance efficacy for up to 16 weeks.

In cycle I of the study, 80 eligible depressed women with breast cancer will be randomized into an 8-week, double-blind, placebo-controlled, flexible-dose vortioxetine (10-20 mg) treatment arm versus placebo arm.

Responders to placebo treatment will complete their study participation at the end of Cycle I, and will not proceed to Cycle II.

Dominique Musselman, M.D., MSCR

The purpose of this antidepressant study is to determine the efficacy of vortioxetine on depression and cognition in 80 women with breast cancer, and to elucidate inflammatory-mediated mechanisms by which depression and its treatment influence cancer outcome. Our hypothesis is that effective vortioxetine antidepressant therapy in depressed women with breast cancer will attenuate increased intermediate endpoints of inflammation that contribute to the pathogenesis of depression, cognitive impairment, and cancer progression

Major depression is an independent risk factor for incident cancer, recurrence and mortality. Women with chronic major depression exhibit a four-fold increased rate of incident breast cancer and a 39% higher mortality rate compared to non-depressed women with breast cancer. Although the precise biological mechanism linking depression with cancer progression remains unclear, elevated concentrations of systemic inflammatory biomarkers (e.g., pro-inflammatory cytokine interleukin-6 (IL-6) and associated cytokine proteins) have been independently associated with depression and cancer progression. In the context of breast cancer, secretion of tumor-derived cytokines is a known mechanism by which epithelial tumors are able to recruit immune cells (MDSCs). The presence of MDSCs at the primary tumor site favors tumor pathogenesis and correlates with more aggressive breast cancer subtypes. At the systemic level, increased levels of interleukin-6, circulating MDSCs, circulating tumor cells (CTCs) and inflammatory markers in the bloodstream of breast cancer patients are found to strongly correlate with poor prognosis.

Medical conditions such as major depression are associated with increased levels of systemic pro-inflammatory cytokines, thereby creating a host environment that promotes cancer progression. Indeed, innate immune activation and chronic inflammation have been implicated in the pathogenesis of major depression and may account for the biological mechanism linking depression and cancer progression. Several studies have shown antidepressant treatment response attenuates and normalizes pro-inflammatory cytokine plasma levels in medically-healthy patients with depression. To date, only three randomized controlled antidepressant studies have been conducted in depressed women with breast cancer. Two studies found mainserin to be effective and superior to placebo, whereas paroxetine and desipramine were comparable to placebo. Notably, several randomized controlled trials in depressed breast cancer patients found psychotherapy to be an effective depression treatment. Moreover, these studies found psychotherapy significantly lengthened survival time in depressed breast cancer patients with metastatic disease. Remarkably, no randomized controlled trials have examined the impact of antidepressant medications on cancer survival.

To date, there have been no randomized, placebo-controlled antidepressant studies in depressed women with breast cancer to investigate the impact of depression treatment on cognition and the inflammatory mediators that promote cancer progression. This study will explore the efficacy of vortioxetine on depression and cognition in women with breast cancer, and determine whether successful treatment of depression alters circulating cytokines, immune mediators, and circulating tumor cells, thus elucidating a possible mechanism to explain improved cancer outcome with effective antidepressant treatment. Given the disproportionately high rate of depression in women with breast cancer and its negative impact on cancer outcome, understanding the biological mechanism that drives this relationship is critical. This study may uncover novel immune-mediated mechanisms by which vortioxetine treatment ameliorates depression, enhances cognition, and influences cancer outcome.

Primary Objective - To assess antidepressant efficacy of vortioxetine (VTX) treatment in women with major depressive disorder (MDD) who have completed curative treatment of Stage I, II or III breast cancer.

Primary Endpoint Antidepressant efficacy will be assessed by the Hamilton Depression Rating Scale-21 (HDRS-21) total score administered at specified time points. Antidepressant response is defined as a 50% reduction in baseline HDRS-21 total score, and treatment remission is defined as an HDRS-21 total score ≤7. Antidepressants will be deemed effective if the patient's depression does not worsen. A participant's depression will be classified as "worse" if a) the participant becomes suicidal or psychotic, b) their HAM-D score increases \> 18, or over a four-week period of time: c) the HAM-D score increases, and d) the CGI Improvement Rating has increased by at least one point. The definitions of antidepressant efficacy and worsening depression remain the same during Cycle 2.

- Cognitive function will be assessed by Brief Assessment of Cognition in Affective Disorders (BAC-A) test battery with measures in: (1) list learning, (2) digit sequencing task, (3) token motor task, (4) verbal fluency, (5) tower of London test, (6) symbol coding, and (7) affective processing subtest. All BAC-A measures will be administered at specified time points, and the total composite z-scores will be compared to baseline total composite z-scores.

Vortioxetine for MDD, Cognition, and Systemic Inflammatory Biomarkers

A Double-blind, Placebo-controlled, Randomized Study of Vortioxetine Treatment on Major Depression, Cognition, and Systemic Inflammatory Biomarkers Associated With Depression and Cancer Progression in Women With Breast Cancer.

Antidepressant efficacy will be assessed by the Hamilton Depression Rating Scale-21 (HDRS-21) total score administered at specified time points. Antidepressant response is defined as a 50% reduction in baseline HDRS-21 total score, and treatment remission is defined as an HDRS-21 total score ≤7. Antidepressants will be deemed effective if the patient's depression does not worsen. A participant's depression will be classified as "worse" if a) the participant becomes suicidal or psychotic, b) their HAM-D score increases \> 18, or over a four-week period of time: c) the HAM-D score increases, and d) the CGI Improvement Rating has increased by at least one point. The definitions of antidepressant efficacy and worsening depression remain the same during Cycle 2.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy	NCT04818099	Radiation Injur...	Vortioxetine 10... Placebo	18 Years - 65 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Vortioxetine for Cancer Patients With Depression: An Observational Study	NCT04253678	Major Depressiv... Cancer	Vortioxetine	18 Years -	University of Malaya
Vortioxetine for MDD, Cognition, and Systemic Inflammatory Biomarkers	NCT02637466	Unipolar Major ... Stage I, II or ...	Vortioxetine	18 Years - 75 Years	University of Miami
Vortioxetine for MDD, Cognition, and Systemic Inflammatory Biomarkers	NCT02637466	Unipolar Major ... Stage I, II or ...	Vortioxetine	18 Years - 75 Years	University of Miami
Vortioxetine in the Treatment of Depression Associated With Head and Neck Cancers Undergoing Radiotherapy	NCT04818099	Radiation Injur...	Vortioxetine 10... Placebo	18 Years - 65 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for vortioxetine

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