Vortioxetine for Cancer Patients With Depression: An Observational Study

January 30, 2020 updated by: Dr Ng Chong Guan, University of Malaya
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chong Guan Ng
        • Sub-Investigator:
          • Sue-Yin Low
        • Sub-Investigator:
          • Aya Ahmed Abousheishaa
        • Sub-Investigator:
          • Nor Zuraida Zainal
      • Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Hospital Kuala Lumpur
        • Contact:
        • Sub-Investigator:
          • Sapini binti Yacob
      • Kuala Lumpur, Malaysia, 50300
        • Recruiting
        • National Cancer Institute
        • Contact:
        • Sub-Investigator:
          • Kai Shin Thong
      • Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • Pusat Perubatan Universiti Kebangsaan Malaysia
        • Contact:
        • Sub-Investigator:
          • Nik Ruzyanei Nik Jaafar
        • Sub-Investigator:
          • Nurul Ain binti Mohamad Kamal
      • Kuala Lumpur, Malaysia, 62250
        • Recruiting
        • Hospital Putrajaya
        • Contact:
        • Sub-Investigator:
          • Kai Shin Thong
        • Contact:
        • Sub-Investigator:
          • Azizul bin Awaluddin
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Not yet recruiting
        • Hospital Raja Permaisuri Bainun, Ipoh
        • Contact:
        • Sub-Investigator:
          • Tsui Huei Loo
    • Selangor
      • Klang, Selangor, Malaysia, 41200
        • Not yet recruiting
        • Hospital Tengku Ampuan Rahimah Klang
        • Contact:
        • Sub-Investigator:
          • Natasha Subhas
      • Sungai Buloh, Selangor, Malaysia, 47000
        • Not yet recruiting
        • Hospital Sungai Buloh
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Chung Wah Lee
        • Sub-Investigator:
          • Muhammad Najib bin Abdullah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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 Names:
  • Brintellix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline (week 1), week 2, week 4, week 8, week 12
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.
baseline (week 1), week 2, week 4, week 8, week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline (week 1), week 2, week 4, week 8, week 12
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).
baseline (week 1), week 2, week 4, week 8, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Chong Guan Ng, UMMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2019

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 30, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOR001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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