Skip to main content
OpenTrials
Completed

NCT Number: NCT02262156

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Epilepsy, Temporal Lobe Epileptic Syndromes Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Neurología y Neurocirugía MVS

México, D.f., 14269, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy

Other

The CBT group will receive 12 weekly 90-minute sessions. Each session will be given in group form by one certified CBT therapist and one neuropsychiatrist in training on group therapy.

The CBT structure include psychoeducation, addressing dysfunctional thoughts and maladaptive behaviors; problem solving techniques, assertiveness, coping strategies and depression relapse prevention

Other names: CBT

SSRI

Drug

Patients will receive the "treatment as usual" with a SSRI: sertraline or citalopram. In patients already taking antidepressants for more than 8 weeks before enrollment but still experiencing depressive symptoms, treatment could be optimized either by augmenting the dose of his antidepressant or by changing to one of the SSRI mentioned.

Other names: selective serotonin reuptake inhibitor, antidepressant

Primary outcomes

  1. Change in Beck Depression Inventory score

    Time frame: baseline, 6 weeks and 12 weeks

Secondary outcomes

  1. Quality of Life in Epilepsy Scale

    Time frame: 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

  2. Hospital anxiety and depression scale (HADS)

    Time frame: baseline, 4weeks and 12 weeks

    the HADS measures severity of symptoms of anxiety and depression. Lower scores indicates less symptoms

Sponsors and collaborators

Lead sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Other

Registry information

Official study title

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

Acronym: CBTvsSSRI

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2014
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.