Clinical trial · Observational
Vortioxetine for Cancer Patients With Depression: An Observational Study
NCT04253678CI-TRIAL-00043194unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Major Depressive Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vortioxetine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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).
- interventionNames
- Drug: Vortioxetine
Primary outcomes (2)
- measure
- Changes in Montgomery-Asberg Depression Rating Scale (MADRS)
- timeFrame
- baseline (week 1), week 2, week 4, week 8, week 12
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.