Depressive Disorder Clinical Trial
Official title:
Dysphoric-like Disorder of Epilepsy, Is it Unique?
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).
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.
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