Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352885
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2006-07-13
Brief Title:
Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
IL-2 Neuropsychiatric Symptoms Mechanism and Prevention
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the effectiveness of an antidepressant in preventing or reducing depressive symptoms in people with melanoma who are receiving Interleukin-2 IL-2 treatment
Detailed Description:
Melanoma is the most serious type of skin cancer affecting nearly 54000 people in the United States each year Melanomas often develop in pre-existing moles or as new moles on the body If left untreated the cancerous cells can spread throughout the body Fortunately melanoma can be cured if a person is diagnosed and treated early Typical treatments include surgery amputation chemotherapy and immunotherapy Interleukin-2 IL-2 treatment a type of immunotherapy uses the bodys immune system to slow or stop the spread of cancer cells to other parts of the body However IL-2 treatment is typically associated with severe side effects including depression fatigue and difficulty thinking This study will evaluate whether escitalopram an antidepressant can help improve treatment-related depressive symptoms reduce stress hormone levels and increase the number of treatment cycles among people with metastatic melanoma who are receiving IL-2 treatment
Participation in this double-blind study will last up to 18 weeks and will include 5 to 14 study visits Participants will complete four 1-week cycles of IL-2 treatment over a 12-week period Two weeks prior to starting IL-2 treatment participants will undergo a psychiatric interview a computerized thinking test questionnaires and blood urine and saliva collection Participants will also be randomly assigned to start receiving either escitalopram or placebo for the entire duration of the study The dosage of escitalopram or placebo will vary depending on the symptom severity of each participant Immediately prior to IL-2 treatment participants will undergo preliminary IL-2 procedures which will include a medical history review physical exam and blood collection These same procedures will occur every day that the participant is in the hospital for IL-2 treatment Participants will stay in the hospital when receiving all four IL-2 treatment cycles During these hospital stays participants will complete repeat questionnaires and computerized tasks Blood collection will occur at selected times as well A follow-up visit will occur 4 weeks after the final treatment dose of IL-2
Participation in this double-blind study will last up to 18 weeks and will include 5 to 14 study visits Participants will complete four 1-week cycles of IL-2 treatment over a 12-week period Two weeks prior to starting IL-2 treatment participants will undergo a psychiatric interview a computerized thinking test questionnaires and blood urine and saliva collection Participants will also be randomly assigned to start receiving either escitalopram or placebo for the entire duration of the study The dosage of escitalopram or placebo will vary depending on the symptom severity of each participant Immediately prior to IL-2 treatment participants will undergo preliminary IL-2 procedures which will include a medical history review physical exam and blood collection These same procedures will occur every day that the participant is in the hospital for IL-2 treatment Participants will stay in the hospital when receiving all four IL-2 treatment cycles During these hospital stays participants will complete repeat questionnaires and computerized tasks Blood collection will occur at selected times as well A follow-up visit will occur 4 weeks after the final treatment dose of IL-2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A3-NSS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH071580 |
| R01MH071580 | NIH | None | None |