Clinical trial NCT04253678: Vortioxetine for Cancer Patients With Depression: An Observational Study
Official title: Vortioxetine for Cancer Patients With Depression: An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depressive Disorder
Cancer
Keywords: depression
cancer
vortioxetine
cognition
quality of life
antidepressant
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: baseline (week 1), week 2, week 4, week 8, week 12
measure: Changes in Perceived Deficits Questionnaire - 5 items (PDQ-5)
timeFrame: baseline (week 1), week 2, week 4, week 8, week 12
Secondary outcomes:
measure: Changes in Clinical Global Impression (CGI)
timeFrame: baseline (week 1), week 2, week 4, week 8, week 12
measure: Changes in EORTC-QLQ-C30
timeFrame: baseline (week 1), week 2, week 4, week 8, week 12
Other outcomes:
Locations:
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun, Ipoh
state: Perak
city: Klang
country: Malaysia
facility: Hospital Tengku Ampuan Rahimah Klang
state: Selangor
city: Sungai Buloh
country: Malaysia
facility: Hospital Sungai Buloh
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: National Cancer Institute
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Pusat Perubatan Universiti Kebangsaan Malaysia
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuala Lumpur
country: Malaysia
facility: Hospital Putrajaya
Study officials:
affiliation: UMMC
name: Chong Guan Ng
role: PRINCIPAL_INVESTIGATOR
References: