Clinical trial · Interventional
Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients
NCT03674138CI-TRIAL-00102611completedN/AClinicalTrials.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)
This is a prospective, randomized clinical trial to investigate the clinical impact of a preemptive pharmacogenomics strategy to guide antidepressant therapy in cancer patients. Those enrolled onto the clinical trial will be randomized to either DNA-guided choice of therapy or clinical management alone. Scores on self-reported measures of depressive and anxiety symptoms along with quality of life will be compared between cohorts.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Depression | — | UNRESOLVED | — |
| Depressive Disorder | — | UNRESOLVED | — |
| Generalized Anxiety Disorder | — | UNRESOLVED | — |
| Major Depressive Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical management | Other | — | UNRESOLVED |
| DNA-guided choice of therapy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- DNA-guided choice of therapy
- description
- DNA-guided choice of antidepressant therapy
- interventionNames
- Diagnostic Test: DNA-guided choice of therapy
- type
- ACTIVE_COMPARATOR
- label
- Clinical management
- description
- Clinical management
- interventionNames
- Diagnostic Test: DNA-guided choice of therapy
- Other: Clinical management
Primary outcomes (2)
- measure
- Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a cancer diagnosis * Be 18 years of age or older * Patients who rate depression or anxiety \> 5 based on a 10 point scale * Patients expected to live greater than 6 months * Serum bilirubin and creatinine \< 1.5x upper limit of normal * AST and ALT \< 3 times upper limit of normal * Willing and able to provide written informed consent * Able to complete self-assessment questionnaires Exclusion Criteria: * Patients not diagnosed with cancer * Antidepressant prescribing performed by a non-Moffitt psychiatrist after enrollment onto the clinical trial * Known Pregnancy * History of liver or allogenic stem cell transplant * Patients with a known cognitive impairment (e.g., delirium, dementia, etc.) or psychological impairment (e.g., schizophrenia, bipolar disease, etc.) other than depressive and anxiety symptoms.
References
Publications (0)
Data not yet available
No reference posted for this study.