Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285831
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2006-01-31
Brief Title:
Mild Depression 2 Week Observational Study
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Dysphoric-like Disorder of Epilepsy Is it Unique
Status:
COMPLETED
Status Verified Date:
2019-09
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:
The purpose of this study is to assess whether the dysphoric-like depressive characteristics observed in people with epilepsy are unique to this patient population in comparison to three control groups Mild Depression enrolled at Stanford University Migraine Headaches enrolled at Long Island Jewish Medical Center and Multiple Sclerosis enrolled at Rush University Medical Center
Detailed Description:
This is a multicenter study consisting of a Screen and Retest phase conducted in two separate days separated by a two-week period After providing written informed consent and meeting protocol-defined inclusion criteria at Screen patients will be administered the Wide Range Achievement Test 3 WRAT3 to ensure adequate word reading ability with which to complete the self-report forms Patients who achieve a satisfactory score will be interviewed using the Mini International Neuropsychiatric Interview MINI Afterwards each patient will first complete the 46 item Mood and Anxiety Symptom List in Epilepsy MAS-E and then five additional questionnaires in random order Patients will also be given the opportunity to be rated by a proxy eg caregiver family member friend who will also complete the MAS-E
Patients will return the completed documents to the investigator and be given an additional MAS-E to take home In the Retest phase patients will be asked to complete the MAS-E again exactly 14 days from the date of the Screen visit The proxy will also be given an additional MAS-E and be asked to complete the MAS-E exactly 14 days from completion of the first MAS-E The documents shall be returned to the clinic via US mail on the same day of completion It is not necessary to have a proxy to participate in this study
Total study participation takes 2 weeks and approximately one visit to the clinic for the screening visit
Patients will return the completed documents to the investigator and be given an additional MAS-E to take home In the Retest phase patients will be asked to complete the MAS-E again exactly 14 days from the date of the Screen visit The proxy will also be given an additional MAS-E and be asked to complete the MAS-E exactly 14 days from completion of the first MAS-E The documents shall be returned to the clinic via US mail on the same day of completion It is not necessary to have a proxy to participate in this study
Total study participation takes 2 weeks and approximately one visit to the clinic for the screening visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None