CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients

Not Applicable

Completed

• Conditions: Epilepsy, Temporal Lobe; Depression
• Interventions: Other: Cognitive behavioral therapy; Drug: SSRI

• Registration Number: NCT02262156
• Lead Sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

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.

Study Timeline

• Study Start: 2014-08
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-10
• Study Completion: 2014-11
• Last Update Submitted: 2015-03-27
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral Therapy	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.
Selective serotonin euptake inhibitor	SSRI	Patients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria.

Primary Outcome Measures

Name	Time	Method
Change in Beck Depression Inventory score	baseline, 6 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of Life in Epilepsy Scale	baseline, 6 weeks and 12 weeks	the quality of life in epilepsy scale measures the patients perceived quality of life. Higher score indicates better quality of life. score goes from 0 to 100
Hospital anxiety and depression scale (HADS)	baseline, 4weeks and 12 weeks	the HADS measures severity of symptoms of anxiety and depression. Lower scores indicates less symptoms

Trial Locations

Locations (1)

Instituto Nacional de Neurología y Neurocirugía MVS; 🇲🇽 MExico, D.f., Mexico