Clinical trial NCT02262156: CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients
Official title: Treatment Of Depression In Patients With Temporal Lobe Epilepsy: Comparative Study Of Cognitive Behavioral Therapy Vs. Selective Serotonin Reuptake Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Epilepsy, Temporal Lobe
Keywords: Cognitive Behavioral Therapy
Selective serotonin reuptake inhibitor
depression
epilepsy
Lead sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effect of group-cognitive-behavioral therapy (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline, in patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder.

Detailed description: patients with temporal lobe epilepsy and depression will be enrolled into one of two treatment modality. The first group will receive 12 group cognitive behavioral sessions. CBT is a psychotherapy focused on the recognition and change of distorted thoughts and maladaptive behaviors.

The second group will receive treatment with the selective serotonin reuptake inhibitor sertraline or citalopram for 12 weeks. This antidepressant is wide used to treat depression in patients with TLE.

Eligibility criteria: Inclusion Criteria:

* With Major depressive disorder according to criteria from the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
* Diagnosed with TLE according to the criteria of the International League Against Epilepsy
* Literates had sign an informed consent
* Patients on antidepressant treatments will be allowed to participate only if they had been at stable doses for more than 8 weeks and still show signs of significant depression

Exclusion Criteria:

* Patients with high risk of suicide who required hospitalization
* Patients who abused or are dependent on drugs
* Those with a history of head trauma six months prior to the interview
* Patients who have any condition that would prevent them from understanding the study or the psychotherapeutic process, such as mental retardation, psychosis, delirium, dementia, etc
* Patients who have previously received CBT
* Patients who have started, an antidepressant drug the last 8 weeks

Primary outcomes:
measure: Change in Beck Depression Inventory score
timeFrame: baseline, 6 weeks and 12 weeks
Secondary outcomes:
measure: Quality of Life in Epilepsy Scale
timeFrame: baseline, 6 weeks and 12 weeks
measure: Hospital anxiety and depression scale (HADS)
timeFrame: baseline, 4weeks and 12 weeks
Other outcomes:
Locations:
city: MExico
country: Mexico
facility: Instituto Nacional de Neurología y Neurocirugía MVS
state: D.f.
Study officials:
affiliation: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
name: Daniel Crail-Melendez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maguire MJ, Marson AG, Nevitt SJ. Antidepressants for people with epilepsy and depression. Cochrane Database Syst Rev. 2021 Apr 16;4(4):CD010682. doi: 10.1002/14651858.CD010682.pub3.