Mild Depression 2 Week Observational Study
Recruitment status was: Active, not recruiting
|Study Design:||Time Perspective: Prospective|
|Official Title:||Dysphoric-Like Disorder of Epilepsy, Is it Unique?|
|Study Start Date:||December 2005|
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 (e.g., 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 U.S. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285831
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||John J Barry||Stanford University|