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Vortioxetine for Cancer Patients With Depression: An Observational Study

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ClinicalTrials.gov Identifier: NCT04253678
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Ng Chong Guan, University of Malaya

Brief Summary:
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.

Condition or disease Intervention/treatment
Major Depressive Disorder Cancer Drug: Vortioxetine

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Vortioxetine for Cancer Patients With Depression: An Observational Study
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).

Drug: Vortioxetine
Flexible dosing from 5mg to 20mg based on attending psychiatrist's discretion
Other Name: Brintellix




Primary Outcome Measures :
  1. Changes in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline (week 1), week 2, week 4, week 8, week 12 ]
    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.

  2. Changes in Perceived Deficits Questionnaire - 5 items (PDQ-5) [ Time Frame: baseline (week 1), week 2, week 4, week 8, week 12 ]
    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.


Secondary Outcome Measures :
  1. Changes in Clinical Global Impression (CGI) [ Time Frame: baseline (week 1), week 2, week 4, week 8, week 12 ]
    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).

  2. Changes in EORTC-QLQ-C30 [ Time Frame: baseline (week 1), week 2, week 4, week 8, week 12 ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Aged between 18 and 65 years old
  • Literate and able to understand English or Malay
  • Diagnosed with Major Depressive Disorder
  • Diagnosed with cancer of any origin

Exclusion Criteria:

  • Medically unstable
  • Delirium
  • Actively psychotic
  • Cognitive deficits of other causes
  • Primary or secondary cerebral/cranial tumors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253678


Contacts
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Contact: Chong Guan Ng 012 3408 813 chong_guan@um.edu.my
Contact: Sue-Yin Low 010 226 3861 lysslsy@gmail.com

Locations
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Malaysia
Hospital Raja Permaisuri Bainun, Ipoh Not yet recruiting
Ipoh, Perak, Malaysia, 30450
Contact: Tsui Huei Loo       tsuihuei@doctor.com   
Sub-Investigator: Tsui Huei Loo         
Hospital Tengku Ampuan Rahimah Klang Not yet recruiting
Klang, Selangor, Malaysia, 41200
Contact: Natasha Subhas       nats085@yahoo.com   
Sub-Investigator: Natasha Subhas         
Hospital Sungai Buloh Not yet recruiting
Sungai Buloh, Selangor, Malaysia, 47000
Contact: Chung Wah Lee       leech316@yahoo.com   
Contact: Muhammad Najib bin Abdullah       phtirus@aol.com   
Sub-Investigator: Chung Wah Lee         
Sub-Investigator: Muhammad Najib bin Abdullah         
National Cancer Institute Recruiting
Kuala Lumpur, Malaysia, 50300
Contact: Kai Shin Thong       kai_shin82@yahoo.com   
Sub-Investigator: Kai Shin Thong         
Hospital Kuala Lumpur Recruiting
Kuala Lumpur, Malaysia, 50586
Contact: Sapini binti Yacob       sapini1975@yahoo.com   
Sub-Investigator: Sapini binti Yacob         
Pusat Perubatan Universiti Kebangsaan Malaysia Recruiting
Kuala Lumpur, Malaysia, 56000
Contact: Nik Ruzyanei Nik Jaafar       njruzyanei@gmail.com   
Sub-Investigator: Nik Ruzyanei Nik Jaafar         
Sub-Investigator: Nurul Ain binti Mohamad Kamal         
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Chong Guan Ng    012 3408 813    chong_guan@um.edu.my   
Contact: Sue-Yin Low    010 226 3861    lysslsy@gmail.com   
Principal Investigator: Chong Guan Ng         
Sub-Investigator: Sue-Yin Low         
Sub-Investigator: Aya Ahmed Abousheishaa         
Sub-Investigator: Nor Zuraida Zainal         
Hospital Putrajaya Recruiting
Kuala Lumpur, Malaysia, 62250
Contact: Kai Shin Thong       kai_shin82@yahoo.com   
Contact: Azizul bin Awaluddin       ppazizul@hpj.gov.my   
Sub-Investigator: Kai Shin Thong         
Sub-Investigator: Azizul bin Awaluddin         
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Chong Guan Ng UMMC
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Responsible Party: Dr Ng Chong Guan, Associate Professor, University of Malaya
ClinicalTrials.gov Identifier: NCT04253678    
Other Study ID Numbers: VOR001
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr Ng Chong Guan, University of Malaya:
depression
cancer
vortioxetine
cognition
quality of life
antidepressant
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Vortioxetine
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists