Clinical trial · Interventional
Venlafaxine for the Prevention of Depression in Patients With Head and Neck Cancer
NCT05724849CI-TRIAL-00073102withdrawnPhase 2ClinicalTrials.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): Issues with funding
Summary
Brief summary (as posted)
This is a pilot double-blinded, randomized, placebo-controlled trial to determine if venlafaxine prevents depression in patients undergoing surgery for Head and Neck Cancer (HNC).
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 |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Venlafaxine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Venlafaxine
- description
- Patients who screen negative or meet criteria for mild MDD are eligible for the randomized control trial (RCT) portion of this study in which patients are randomized into either the intervention (venlafaxine) arm or placebo. Participants randomized into the intervention group will be prescribed a starting dose of venlafaxine immediate release (IR) 75mg once daily. The dosing will be increased at the following rate: Week 1: 75mg in AM Week 2: 75mg BID Week 3: 150mg in AM, 75mg in PM Week 4: 150mg BID For patients with hepatic impairment, severe renal impairment, or end stage kidney disease, the starting dose is 37.5 mg once daily, increased by increments of 37.5 mg per day to reach a maximum of 187.5 mg per day, given in two divided doses.
- interventionNames
- Drug: Venlafaxine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients who screen negative or meet criteria for mild MDD are eligible for the randomized control trial (RCT) portion of this study in which patients are randomized into either the intervention (venlafaxine) arm or placebo. Participants randomized to the placebo group will receive a placebo capsule with the same dosing schedule as the intervention group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: COHORT A (RCT) 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. Have a recently diagnosed cutaneous or mucosal malignancy 5. Scheduled to undergo surgical treatment for their malignancy with curative intent 6. Ability to take medication orally or via gastric tube feeds 7. Willing to adhere to the study drug's dosing protocol 8. Score \<10 on the PHQ-9 COHORT B (Observation cohort) 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. Have a recently diagnosed cutaneous or mucosal malignancy 5. Scheduled to undergo surgical treatment for their malignancy with curative intent 6. Ability to take medication orally or via gastric tube feeds 7. Willing to adhere to the study drug's dosing protocol 8. Score \>10 on the PHQ-9 Exclusion Criteria: COHORT A (RCT) 1. Score \>10 on PHQ-9 2. Score between 5-9 on PHQ-9 and elect for psychotherapy 3. Age less than 18 years 4. Primary malignancy of thyroid or parathyroid origin 5. Currently meet diagnostic criteria for psychosis, schizophrenia, or bipolar disorder 6. Currently receiving medication as treatment for depression or anxiety including: MAO inhibitors, Linezolid, Other SNRIs or SSRIs, Bupropion 7. Known allergic reaction to components of study drug 8. Treatment with another investigational drug or other intervention within 30 days 9. Females of child-bearing age who are pregnant or nursing 10. Inability to speak or understand English COHORT B (Observation cohort) 1. Score \<10 on PHQ-9 2. Unwillingness or inability to take venlafaxine 3. Age less than 18 years 4. Primary malignancy of thyroid or parathyroid origin 5. Currently receiving medication as treatment for depression or anxiety including: MAO inhibitors, Linezolid, Other SNRIs or SSRIs, Bupropion 7\. Known allergic reaction to components of study drug 8. Treatment with another investigational drug or other intervention within 30 days 9. Females of child-bearing age who are pregnant or nursing 10. Inability to speak or understand English
References
Publications (11)
- BACKGROUNDLydiatt WM, Moran J, Burke WJ. A review of depression in the head and neck cancer patient. Clin Adv Hematol Oncol. 2009 Jun;7(6):397-403. PMID 19606075
- BACKGROUNDChhabria KS, Carnaby GD. Psychometric validation of the Center for Epidemiological Studies Depression Scale in Head and Neck Cancer patients. Oral Oncol. 2017 Dec;75:158-162. doi: 10.1016/j.oraloncology.2017.11.010. Epub 2017 Nov 15. PMID 29224813
- BACKGROUNDRieke K, Schmid KK, Lydiatt W, Houfek J, Boilesen E, Watanabe-Galloway S. Depression and survival in head and neck cancer patients. Oral Oncol. 2017 Feb;65:76-82. doi: 10.1016/j.oraloncology.2016.12.014. Epub 2017 Jan 1. PMID 28109472
- BACKGROUNDArcher J, Hutchison I, Korszun A. Mood and malignancy: head and neck cancer and depression. J Oral Pathol Med. 2008 May;37(5):255-70. doi: 10.1111/j.1600-0714.2008.00635.x. Epub 2008 Feb 26. PMID 18312300
- BACKGROUNDCramer JD, Johnson JT, Nilsen ML. Pain in Head and Neck Cancer Survivors: Prevalence, Predictors, and Quality-of-Life Impact. Otolaryngol Head Neck Surg. 2018 Nov;159(5):853-858. doi: 10.1177/0194599818783964. Epub 2018 Jun 26. PMID 29943677
- BACKGROUNDFriedland CJ. Head and Neck Cancer: Identifying Depression as a Comorbidity Among Patients. Clin J Oncol Nurs. 2019 Feb 1;23(1):99-102. doi: 10.1188/19.CJON.99-102. PMID 30681992
- BACKGROUNDBarber B, Dergousoff J, Slater L, Harris J, O'Connell D, El-Hakim H, Biron VL, Mitchell N, Seikaly H. Depression and Survival in Patients With Head and Neck Cancer: A Systematic Review. JAMA Otolaryngol Head Neck Surg. 2016 Mar;142(3):284-8. doi: 10.1001/jamaoto.2015.3171. PMID 26796781
- BACKGROUNDLydiatt WM, Denman D, McNeilly DP, Puumula SE, Burke WJ. A randomized, placebo-controlled trial of citalopram for the prevention of major depression during treatment for head and neck cancer. Arch Otolaryngol Head Neck Surg. 2008 May;134(5):528-35. doi: 10.1001/archotol.134.5.528.