Cancer Clinical Trial
Official title:
Vortioxetine for Cancer Patients With Depression: An Observational Study
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.
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