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

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Status: Completed

Conditions: Epilepsy, Temporal Lobe; Depression

Treatments: Drug: SSRI; Other: Cognitive behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02262156

U1111-1158-3147 (Other Identifier)

49/06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Cognitive behavioral Therapy

Experimental group

Description:

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.

Treatment:

Other: Cognitive behavioral therapy

Selective serotonin euptake inhibitor

Active Comparator group

Description:

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

Treatment:

Drug: SSRI