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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | Flexible dosing from 5mg to 20mg based on attending psychiatrist's discretion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Montgomery-Asberg Depression Rating Scale (MADRS) | 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. | baseline (week 1), week 2, week 4, week 8, week 12 |
| Changes in Perceived Deficits Questionnaire - 5 items (PDQ-5) | 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. | baseline (week 1), week 2, week 4, week 8, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Clinical Global Impression (CGI) | 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). | baseline (week 1), week 2, week 4, week 8, week 12 |
| Changes in EORTC-QLQ-C30 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with cancer of any origin who are diagnosed with Major Depressive Disorder based on DSM 5 will be screened for the study. Those consented will be enrolled in the observational study. The total target sample size will be 140 subjects. The study will be conducted at the psychiatric clinic (Psycho-oncology clinic on every Thursday) in University Malaya Medical Centre as a main centre as well as other centres in Malaysia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chong Guan Ng | Contact | 012 3408 813 | chong_guan@um.edu.my | |
| Sue-Yin Low | Contact | 010 226 3861 | lysslsy@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chong Guan Ng | UMMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Raja Permaisuri Bainun, Ipoh | Not yet recruiting | Ipoh | Perak | 30450 | Malaysia |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D009369 | Neoplasms |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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). |
| baseline (week 1), week 2, week 4, week 8, week 12 |
| Hospital Tengku Ampuan Rahimah Klang | Not yet recruiting | Klang | Selangor | 41200 | Malaysia |
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| Hospital Sungai Buloh | Not yet recruiting | Sungai Buloh | Selangor | 47000 | Malaysia |
|
| National Cancer Institute | Recruiting | Kuala Lumpur | 50300 | Malaysia |
|
| Hospital Kuala Lumpur | Recruiting | Kuala Lumpur | 50586 | Malaysia |
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| Pusat Perubatan Universiti Kebangsaan Malaysia | Recruiting | Kuala Lumpur | 56000 | Malaysia |
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| University Malaya Medical Centre | Recruiting | Kuala Lumpur | 59100 | Malaysia |
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| Hospital Putrajaya | Recruiting | Kuala Lumpur | 62250 | Malaysia |
|
| D001519 |
| Behavior |