Clinical trial · Interventional
Mood Disorders in Head and Neck Cancer Patients
Serotonin-Norepinephrine Reuptake Inhibitors for the Prevention and Treatment of Pain, Depression, and Anxiety in Patients With Head & Neck Cancer
NCT04977271CI-TRIAL-00085450withdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study never opened
Summary
Brief summary (as posted)
The purpose of this research study is to initiate a pharmacotherapy protocol for at-risk patients with newly diagnosed head and neck cancer in order to decrease the incidence of anxiety, depression, and uncontrolled pain during cancer treatment.
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 |
|---|---|---|---|
| Depressive Disorder | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venlafaxine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Starting dose of oral venlafaxine immediate release (IR) 37.5 mg BID, to be taken with food. The dosing will be increased at a rate of 75mg per week for 3 weeks, to reach a desired dose of 300mg per day, taken as 150mg BID. For patients with hepatic impairment, severe renal impairment, or end-stage kidney disease, the starting dose is 37.5 mg once daily, and the dose is increased by increments of 37.5 mg per day, to a maximum of 187.5 mg per day, taken as 93.75 mg BID.
- interventionNames
- Drug: Venlafaxine
- type
- NO_INTERVENTION
- label
- Control Group
- description
- No intervention will be provided for this group
Primary outcomes (1)
- measure
- The rate of depression in patients undergoing treatment for head and neck cancer (HNC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years or older 4. Ability to speak and understand English 5. Have a recently diagnosed cutaneous or mucosal malignancy 6. Scheduled to undergo treatment for their malignancy (surgical or nonsurgical) with curative intent 7. Ability to take medication (by mouth or via parenteral route) 8. Willing to adhere to the study drug's dosing protocol Exclusion Criteria: 1. Age less than 18 years 2. Inability to speak or understand English 3. Primary malignancy of thyroid or parathyroid origin 4. Currently meet diagnostic criteria for psychosis, schizophrenia, or moderate/severe major depressive disorder (MDD) 5. Currently receiving medication as treatment for depression or anxiety 6. Known allergic reaction to components of study drug 7. Have uncontrolled pain or chronic pain disorder 8. Treatment with another investigational drug or other intervention within 30 days 9. Females of child-bearing age who are pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.