Vortioxetine for Cancer Patients With Depression: An Observational Study

Last updated: January 30, 2020
Sponsor: University of Malaya
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Depression

Affective Disorders

Treatment

N/A

Clinical Study ID

NCT04253678
VOR001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Medically unstable

  • Delirium

  • Actively psychotic

  • Cognitive deficits of other causes

  • Primary or secondary cerebral/cranial tumors

Study Design

Total Participants: 140
Study Start date:
December 12, 2019
Estimated Completion Date:
July 31, 2020

Study 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.

Connect with a study center

  • Hospital Raja Permaisuri Bainun, Ipoh

    Ipoh, Perak 30450
    Malaysia

    Site Not Available

  • Hospital Tengku Ampuan Rahimah Klang

    Klang, Selangor 41200
    Malaysia

    Site Not Available

  • Hospital Sungai Buloh

    Sungai Buloh, Selangor 47000
    Malaysia

    Site Not Available

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586
    Malaysia

    Active - Recruiting

  • Hospital Putrajaya

    Kuala Lumpur, 62250
    Malaysia

    Active - Recruiting

  • National Cancer Institute

    Kuala Lumpur, 50300
    Malaysia

    Active - Recruiting

  • Pusat Perubatan Universiti Kebangsaan Malaysia

    Kuala Lumpur, 56000
    Malaysia

    Active - Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

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