Major Depressive DisorderNCT04253678
Vortioxetine for Cancer Patients With Depression: An Observational Study
An observational study of Major Depressive Disorder and Cancer, run by University of Malaya at 8 sites in Malaysia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Cancer
- What is being tested?
- Vortioxetine
- How many people
- 140 participants
- Where
- 8 sitesMalaysia
- Study dates
- 12 Dec 2019to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Medically unstable
- Delirium
- Actively psychotic
- Cognitive deficits of other causes
- Primary or secondary cerebral/cranial tumors
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Malaysia8 sites, 8 recruiting
- Not yet recruiting
Hospital Raja Permaisuri Bainun, Ipoh
Ipoh, Perak, 30450
Tsui Huei Loo, tsuihuei@doctor.com
Tsui Huei Loo
- Not yet recruiting
Hospital Tengku Ampuan Rahimah Klang
Klang, Selangor, 41200
Natasha Subhas, nats085@yahoo.com
Natasha Subhas
- Recruiting
National Cancer Institute
Kuala Lumpur, 50300
Kai Shin Thong, kai_shin82@yahoo.com
Kai Shin Thong
- Recruiting
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Sapini binti Yacob, sapini1975@yahoo.com
Sapini binti Yacob
- Recruiting
Pusat Perubatan Universiti Kebangsaan Malaysia
Kuala Lumpur, 56000
Nik Ruzyanei Nik Jaafar, njruzyanei@gmail.com
Nik Ruzyanei Nik Jaafar
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, 59100
Chong Guan Ng, 012 3408 813, chong_guan@um.edu.my
Sue-Yin Low, 010 226 3861, lysslsy@gmail.com
- Recruiting
Hospital Putrajaya
Kuala Lumpur, 62250
Kai Shin Thong, kai_shin82@yahoo.com
Azizul bin Awaluddin, ppazizul@hpj.gov.my
- Not yet recruiting
Hospital Sungai Buloh
Sungai Buloh, Selangor, 47000
Chung Wah Lee, leech316@yahoo.com
Muhammad Najib bin Abdullah, phtirus@aol.com
About this 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.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Major Depressive Disorder, Cancer
- Being tested
- Vortioxetine
- Keywords
- depression, cancer, vortioxetine, cognition, quality of life, antidepressant
- Medical subject headings
- Depressive Disorder, Major, Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Also called Brintellix
Flexible dosing from 5mg to 20mg based on attending psychiatrist's discretion
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Vortioxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline (week 1), week 2, week 4, week 8, week 12
Secondary outcomes (2)
Changes in Clinical Global Impression (CGI)
The CGI allows psychiatrist to assess the patient's condition relative to baseline and rate the change on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: baseline (week 1), week 2, week 4, week 8, week 12
Changes in EORTC-QLQ-C30
The EORTC QLQ-C30 is widely used clinical scale for measurement of cancer-specific quality of life. It contains five functioning scales (physical, social, role, cognitive, and emotional functioning), eight symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, and diarrhea), financial impact, and overall quality of life. All scale scores are linearly converted to range from 0 to 100. For the functioning scales and global QOL higher scores indicate better functioning; for the symptom scales higher scores indicate higher symptom burden (Aaronson et al., 1993).
Measured: baseline (week 1), week 2, week 4, week 8, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start12 Dec 2019
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ng Chong Guan, University of Malaya
- Investigators
- Chong Guan Ng, Principal investigator, UMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253678
- Sponsor's protocol ID
- VOR001
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vortioxetine for Cancer Patients With Depression: An Observational Study
- ClinicalTrials.gov ID
- NCT04253678
- Acronym / sponsor ID
- VOR001
- Conditions
- Major Depressive Disorder, Cancer
- Keywords
- depression, cancer, vortioxetine, cognition, quality of life, antidepressant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: VortioxetineStudy 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Medically unstable
- Delirium
- Actively psychotic
- Cognitive deficits of other causes
- Primary or secondary cerebral/cranial tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VortioxetineAlso: BrintellixFlexible dosing from 5mg to 20mg based on attending psychiatrist's discretion | Drug | Study group |
Primary outcome
Changes in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: baseline (week 1), week 2, week 4, week 8, week 12
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.
Changes in Perceived Deficits Questionnaire - 5 items (PDQ-5)
Time frame: baseline (week 1), week 2, week 4, week 8, week 12
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.
2 secondary outcomes
Changes in Clinical Global Impression (CGI)
Time frame: baseline (week 1), week 2, week 4, week 8, week 12
Changes in EORTC-QLQ-C30
Time frame: baseline (week 1), week 2, week 4, week 8, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chong Guan Ng principal investigator
UMMC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Cancer, run by University of Malaya at 8 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chong Guan Ng (012 3408 813, chong_guan@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: baseline (week 1), week 2, week 4, week 8, week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.