Depression Temporal Lobe Epilepsy with hippocampal sclerosis
Conditions
Interventions
Active Comparator: Sertraline
Number of participants: 25
Drug: sertraline
Sertraline – 25-200mg PO (orally)
Subjects begin at 25mg for week 1 and increase to 50mg at the beginning of week 2. Sertraline is increased in 50mg increments when subjects score in the depressed range on the BDI-II (BDI-II>14), a qu
Drug
Behavioural
F04.754.137
Sponsors
Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Must have a TLE-HS; must be age 18 to 59 years old; must meet the DSM-5 criteria for major depression; must be willing to provide written informed consent; must be compliant, cooperative, reliable, and able to follow instructions, and to visit the clinic on schedule; must have an intellectual level (IQ) of 80 or more; must have a diagnosis of active epilepsy for at least six months and be receiving appropriate neurological treatment; doses of the antiseizure medication should be stable at least eight weeks ago, to start to receive a treatment of this study.
Exclusion criteria
Exclusion criteria: Have other epileptic syndromes; presence of injury detectable to brain MRI other than that characterizing HS; history of other central nervous system disorder, such as meningitis, tumor, multiple sclerosis or traumatic brain injury; have clinical signs of drug intoxication or any other condition that may cause or predispose to severe impairment of cognition; have diagnosis of psychotic disorder, even though this condition is under remission; have severe psychiatric disorder requiring emergency treatment (e.g. psychosis); have active suicidal or homicidal ideation; have current alcohol or other substance abuse disorders or a history of bipolar depression or any psychotic disorder. Are pregnant or lactating; are known to be hypersensitive to sertraline; currently taking an antidepressant medication or seeing a therapist regularly; unable to understand or to complete the questionnaires or to participate in treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modification of the diagnosis of major depressive disorder, verified through SCID [baseline (before intervention); after the 6th intervention session; soon after the end of treatment; three and six months after the end of treatment].;Decreased depressive symptoms as measured by the BDI-II, HAMS, HADS, and NDDIE [Time Frame: baseline (before intervention); every 2 weeks during the 12 week intervention period; after the 6th intervention session; soon after the end of treatment; three and six months after the end of treatment]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Decreased anxiety symptoms as measured by STAI, HADS, and suicidality index of MINI [Time Frame: baseline (before intervention); after the 6th intervention session; soon after the end of treatment; three and six months after the end of treatment]. ;Improvement in social adjustment as measured by SAS-self report [Time Frame: baseline (before intervention); after the 6th intervention session; soon after the end of treatment; three and six months after the end of treatment].;Improvement in health Related Quality of life as measured by the QOILIE-31, and WHOQOL-brief [Time Frame: baseline (before intervention); after the 6th intervention session; soon after the end of treatment; three and six months after the end of treatment].;Tertiary Outcome Measures: Improvement in coping skills and environmental reward as measured by BADS, and EROS [Time Frame: baseline (before intervention); after the 6th intervention session; soon after the end of treatment; three and six months after the end of treatment]. ;Improvement in antiepileptic medication compliance [Time Frame: baseline (before intervention); assessed at 12 weeks; soon after the end of treatment; three and six months after the end of treatment]. ;Decreased antiepileptic medication toxicity and complaints about antiepileptic medication as measured by the LAEP [Time Frame: baseline (before intervention); after the 6th intervention session; soon after the end of treatment; three and six months after the end of treatment]. ;Decreased seizure frequency and seizure severity [Time Frame: baseline (before intervention); assessed at 12 weeks, by seizure diary; soon after the end of treatment; three and six months after the end of treatment]. ;Stability or improved neuropsychological functioning as measured by neuropsychological assessment [Time Frame: baseline (before intervention); three months after the end of treatment]. | — |
Countries
Brazil
Contacts
Public ContactEllen Lima
Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed