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

March 27, 2015 updated by: Edgar Daniel Crail Melendez, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • D.f.
      • MExico, D.f., Mexico, 14269
        • Instituto Nacional de Neurologia Y Neurocirugia Mvs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: Cognitive behavioral therapy

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
ACTIVE_COMPARATOR: 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.
Drug: SSRI
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Beck Depression Inventory score
Time Frame: baseline, 6 weeks and 12 weeks
baseline, 6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 6 weeks and 12 weeks
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
baseline, 4weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Investigators

  • Principal Investigator: Daniel Crail-Melendez, MD, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

October 7, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (ESTIMATE)

October 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 27, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49/06
  • U1111-1158-3147 (OTHER: WHO UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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