Vortioxetine for Cancer Patients With Depression: An Observational Study
1 other identifier
observational
140
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2019
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2019
CompletedFirst Submitted
Initial submission to the registry
January 28, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedFebruary 5, 2020
January 1, 2020
7 months
January 28, 2020
January 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in Montgomery-Asberg Depression Rating Scale (MADRS)
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)
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 Outcomes (2)
Changes in Clinical Global Impression (CGI)
baseline (week 1), week 2, week 4, week 8, week 12
Changes in EORTC-QLQ-C30
baseline (week 1), week 2, week 4, week 8, week 12
Study Arms (1)
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).
Interventions
Flexible dosing from 5mg to 20mg based on attending psychiatrist's discretion
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Medically unstable
- Delirium
- Actively psychotic
- Cognitive deficits of other causes
- Primary or secondary cerebral/cranial tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Hospital Raja Permaisuri Bainun, Ipoh
Ipoh, Perak, 30450, Malaysia
Hospital Tengku Ampuan Rahimah Klang
Klang, Selangor, 41200, Malaysia
Hospital Sungai Buloh
Sungai Buloh, Selangor, 47000, Malaysia
National Cancer Institute
Kuala Lumpur, 50300, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
Pusat Perubatan Universiti Kebangsaan Malaysia
Kuala Lumpur, 56000, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Putrajaya
Kuala Lumpur, 62250, Malaysia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chong Guan Ng
UMMC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 28, 2020
First Posted
February 5, 2020
Study Start
December 12, 2019
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
February 5, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share