ClinicalTrials.Veeva

Menu

Vortioxetine for Cancer Patients With Depression: An Observational Study

U

University of Malaya

Status

Unknown

Conditions

Major Depressive Disorder
Cancer

Treatments

Drug: Vortioxetine

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

140 participants in 1 patient group

Study group
Description:
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).
Treatment:
Drug: Vortioxetine

Trial contacts and locations

8

Loading...

Central trial contact

Sue-Yin Low; Chong Guan Ng

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems