Depressive DisorderPhase 4NCT04977271
Mood Disorders in Head and Neck Cancer Patients
A Phase 4 study testing Venlafaxine in people with Depressive Disorder and Head and Neck Cancer, run by University of Alabama at Birmingham.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Head and Neck Cancer
- What is being tested?
- Venlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2024to 1 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Ability to speak and understand English
- Have a recently diagnosed cutaneous or mucosal malignancy
- Scheduled to undergo treatment for their malignancy (surgical or nonsurgical) with curative intent
- Ability to take medication (by mouth or via parenteral route)
- Willing to adhere to the study drug's dosing protocol
Who cannot join
- Age less than 18 years
- Inability to speak or understand English
- Primary malignancy of thyroid or parathyroid origin
- Currently meet diagnostic criteria for psychosis, schizophrenia, or moderate/severe major depressive disorder (MDD)
- Currently receiving medication as treatment for depression or anxiety
- Known allergic reaction to components of study drug
Show all 9Show fewer
- Have uncontrolled pain or chronic pain disorder
- Treatment with another investigational drug or other intervention within 30 days
- Females of child-bearing age who are pregnant or nursing
About this study
Official title: Serotonin-Norepinephrine Reuptake Inhibitors for the Prevention and Treatment of Pain, Depression, and Anxiety in Patients With Head & Neck Cancer
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.
Read the detailed description
Patients requiring treatment of his or her newly diagnosed mucosal or cutaneous head and neck cancer per standard of care guidelines that meet all enrollment criteria will be identified and enrolled after obtaining informed consent. This will occur in the clinic setting, and subsequent screening and work up will be performed.
Enrolled patients will be randomized into one of the two study groups (Treatment v Control) via a computer-based program.
Treatment Group: Participants will be prescribed a starting dose of venlafaxine immediate release (IR) 37.5 mg twice daily. The IR formulation was selected due to its ability to be crushed for those patients who rely on parenteral administration of medications. The dosing will be increased at a rate of 75mg per week, to reach a desired dose of 300mg, divided into 150mg BID dosing. This dosing was selected due to the need for at least 150mg to see noradrenergic effects. 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, given in two divided doses.
Control Group: Participants will not receive any pharmacological treatment.
Patients in the Treatment Group will meet with a dedicated research collaborator via telephone on a weekly visit (for a maximum of 3 visits) as the medication is being titrated up to ensure tolerability. If at any point there are side effects or concerns regarding tolerability of medication, a collaborating psychiatrist who specializes in treatment of depression is available for consultation.
Patients in both groups will follow up 6-8 weeks after beginning their chosen treatment regimen for their HNC as determined for them by their standard of care evaluation. They will complete all of the study questionnaires at this visit. Vital signs will be collected at this visit as well as concomitant medications and any adverse events they may be experiencing.
Follow-up visits will continue every three months following this visit per the patient's standard of care return to clinic visits. It is anticipated that participants will be seen in clinic during Months 6, 9, and 12 as follow up for their standard of care treatment regimen. Vital signs, concomitant medications, adverse events, and responses to questionnaires will be collected at these visits.
Participant duration will be up to one year. If at any point, patients meet criteria for MDD, they will be referred to a mental health counselor.
- Conditions
- Depressive Disorder, Head and Neck Cancer
- Being tested
- Venlafaxine
- Medical subject headings
- Depressive Disorder, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
Also called Effexor
The Immediate Release generic formulation of this drug will be used due to its ability to be crushed for those patients who rely on parenteral administration of medications.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Drug: Venlafaxine |
| Control Group | No intervention | No intervention will be provided for this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of depression in patients undergoing treatment for head and neck cancer (HNC)
The degree of depression in patients who currently do not show signs of depression at the beginning of undergoing HNC treatment. This will be assessed using the following validated questionnaires: Patient-Health Questionnaire (PHQ-9) and the Quick Inventory of Depressive Symptomatology (QIDS SR-16). For both questionnaires, an increase in score is considered to show a higher degree of depression.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start5 Jan 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Why it stopped: study never opened
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harishanker Jeyarajan, University of Alabama at Birmingham
- Investigators
- Jessica Grayson, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977271
- Sponsor's protocol ID
- IRB-300007057
- Status last verified
- Jan 2025
- First submitted
- 15 Jul 2021
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotonin-Norepinephrine Reuptake Inhibitors for the Prevention and Treatment of Pain, Depression, and Anxiety in Patients With Head & Neck Cancer
- ClinicalTrials.gov ID
- NCT04977271
- Acronym / sponsor ID
- IRB-300007057
- Conditions
- Depressive Disorder, Head and Neck Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study never opened
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients requiring treatment of his or her newly diagnosed mucosal or cutaneous head and neck cancer per standard of care guidelines that meet all enrollment criteria will be identified and enrolled after obtaining informed consent. This will occur in the clinic setting, and subsequent screening and work up will be performed.
Enrolled patients will be randomized into one of the two study groups (Treatment v Control) via a computer-based program.
Treatment Group: Participants will be prescribed a starting dose of venlafaxine immediate release (IR) 37.5 mg twice daily. The IR formulation was selected due to its ability to be crushed for those patients who rely on parenteral administration of medications. The dosing will be increased at a rate of 75mg per week, to reach a desired dose of 300mg, divided into 150mg BID dosing. This dosing was selected due to the need for at least 150mg to see noradrenergic effects. 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, given in two divided doses.
Control Group: Participants will not receive any pharmacological treatment.
Patients in the Treatment Group will meet with a dedicated research collaborator via telephone on a weekly visit (for a maximum of 3 visits) as the medication is being titrated up to ensure tolerability. If at any point there are side effects or concerns regarding tolerability of medication, a collaborating psychiatrist who specializes in treatment of depression is available for consultation.
Patients in both groups will follow up 6-8 weeks after beginning their chosen treatment regimen for their HNC as determined for them by their standard of care evaluation. They will complete all of the study questionnaires at this visit. Vital signs will be collected at this visit as well as concomitant medications and any adverse events they may be experiencing.
Follow-up visits will continue every three months following this visit per the patient's standard of care return to clinic visits. It is anticipated that participants will be seen in clinic during Months 6, 9, and 12 as follow up for their standard of care treatment regimen. Vital signs, concomitant medications, adverse events, and responses to questionnaires will be collected at these visits.
Participant duration will be up to one year. If at any point, patients meet criteria for MDD, they will be referred to a mental health counselor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: VenlafaxineStarting 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. |
| Control Group | No intervention | –No intervention will be provided for this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Ability to speak and understand English
- Have a recently diagnosed cutaneous or mucosal malignancy
Key exclusion criteria (9 listed)
- Age less than 18 years
- Inability to speak or understand English
- Primary malignancy of thyroid or parathyroid origin
- Currently meet diagnostic criteria for psychosis, schizophrenia, or moderate/severe major depressive disorder (MDD)
- Currently receiving medication as treatment for depression or anxiety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenlafaxineAlso: EffexorThe Immediate Release generic formulation of this drug will be used due to its ability to be crushed for those patients who rely on parenteral administration of medications. | Drug | Treatment Group |
Primary outcome
The rate of depression in patients undergoing treatment for head and neck cancer (HNC)
Time frame: Baseline to 12 months
The degree of depression in patients who currently do not show signs of depression at the beginning of undergoing HNC treatment. This will be assessed using the following validated questionnaires: Patient-Health Questionnaire (PHQ-9) and the Quick Inventory of Depressive Symptomatology (QIDS SR-16). For both questionnaires, an increase in score is considered to show a higher degree of depression.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Grayson, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Venlafaxine in people with Depressive Disorder and Head and Neck Cancer, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of depression in patients undergoing treatment for head and neck cancer (HNC) (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.