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Clinical Trials/NCT02262156
NCT02262156
Completed
N/A

Treatment Of Depression In Patients With Temporal Lobe Epilepsy: Comparative Study Of Cognitive Behavioral Therapy Vs. Selective Serotonin Reuptake Inhibitors

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez1 site in 1 country15 target enrollmentAugust 2014

Overview

Phase
N/A
Intervention
Cognitive behavioral therapy
Conditions
Depression
Sponsor
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Enrollment
15
Locations
1
Primary Endpoint
Change in Beck Depression Inventory score
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Responsible Party
Principal Investigator
Principal Investigator

Edgar Daniel Crail Melendez

Md

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

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

Arms & Interventions

Cognitive behavioral Therapy

CBT program to be used in group modality that focused on managing symptoms of depression in patients with epilepsy. 12 CBT sessions, consisting of one weekly 90-minute session for 12 consecutive weeks.

Intervention: Cognitive behavioral therapy

Selective serotonin euptake inhibitor

Patients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria.

Intervention: SSRI

Outcomes

Primary Outcomes

Change in Beck Depression Inventory score

Time Frame: baseline, 6 weeks and 12 weeks

Secondary Outcomes

  • Quality of Life in Epilepsy Scale(baseline, 6 weeks and 12 weeks)
  • Hospital anxiety and depression scale (HADS)(baseline, 4weeks and 12 weeks)

Study Sites (1)

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