Venlafaxine for the Prevention of Depression in Patients With Head and Neck Cancer
Megadott ok: Issues with funding
Key facts
- Phase
- 2. fázis
Trial details
- Who runs it
- Vanderbilt University Medical Center
- Trial code
- NCT05724849
- Record updated
- 2024. január 18.
- Original description
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).Read full original descriptionShow less
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).
Inclusion: COHORT A (RCT); Provision of signed and dated informed consent form; Stated willingness to comply with all study procedures and availability for the duration of the study; Male or female, aged 18 years or older; Have a recently diagnosed cutaneous or mucosal malignancy; Scheduled to undergo surgical treatment for their malignancy with curative intent; Ability to take medication orally or via gastric tube feeds; Willing to adhere to the study drug's dosing protocol; Score <10 on the PHQ-9; COHORT B (Observation cohort); Provision of signed and dated informed consent form; Stated willingness to comply with all study procedures and availability for the duration of the study; Male or female, aged 18 years or older; Have a recently diagnosed cutaneous or mucosal malignancy; Scheduled to undergo surgical treatment for their malignancy with curative intent; Ability to take medication orally or via gastric tube feeds; Willing to adhere to the study drug's dosing protocol; Score >10 on the PHQ-9.
Exclusion: Currently receiving medication as treatment for depression or anxiety including: MAO inhibitors, Linezolid, Other SNRIs or SSRIs, Bupropion; Treatment with another investigational drug or other intervention within 30 days; Currently receiving medication as treatment for depression or anxiety including: MAO inhibitors, Linezolid, Other SNRIs or SSRIs, Bupropion; 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; Primary malignancy of thyroid or parathyroid origin; Currently meet diagnostic criteria for psychosis, schizophrenia, or bipolar disorder; Known allergic reaction to components of study drug; Primary malignancy of thyroid or parathyroid origin; Age less than 18 years; Females of child-bearing age who are pregnant or nursing; Age less than 18 years; COHORT A (RCT); Score >10 on PHQ-9; Score between 5-9 on PHQ-9 and elect for psychotherapy; Inability to speak or understand English; COHORT B (Observation cohort); Score <10 on PHQ-9; Unwillingness or inability to take venlafaxine.