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

Primary Purpose

Depression, Epilepsy, Temporal Lobe

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Cognitive behavioral therapy
SSRI
Sponsored by
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Cognitive Behavioral Therapy, Selective serotonin reuptake inhibitor, depression, epilepsy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Instituto Nacional de Neurología y Neurocirugía MVS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive behavioral Therapy

Selective serotonin euptake inhibitor

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in Beck Depression Inventory score

Secondary Outcome Measures

Quality of Life in Epilepsy Scale
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)
the HADS measures severity of symptoms of anxiety and depression. Lower scores indicates less symptoms

Full Information

First Posted
October 7, 2014
Last Updated
March 27, 2015
Sponsor
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
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1. Study Identification

Unique Protocol Identification Number
NCT02262156
Brief Title
CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients
Acronym
CBTvsSSRI
Official Title
Treatment Of Depression In Patients With Temporal Lobe Epilepsy: Comparative Study Of Cognitive Behavioral Therapy Vs. Selective Serotonin Reuptake Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Epilepsy, Temporal Lobe
Keywords
Cognitive Behavioral Therapy, Selective serotonin reuptake inhibitor, depression, epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioral Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Selective serotonin euptake inhibitor
Arm Type
Active Comparator
Arm Description
Patients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria.
Intervention Type
Other
Intervention Name(s)
Cognitive behavioral therapy
Other Intervention Name(s)
CBT
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
SSRI
Other Intervention Name(s)
selective serotonin reuptake inhibitor, antidepressant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Beck Depression Inventory score
Time Frame
baseline, 6 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Quality of Life in Epilepsy Scale
Description
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
Time Frame
baseline, 6 weeks and 12 weeks
Title
Hospital anxiety and depression scale (HADS)
Description
the HADS measures severity of symptoms of anxiety and depression. Lower scores indicates less symptoms
Time Frame
baseline, 4weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Crail-Melendez, MD
Organizational Affiliation
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Neurología y Neurocirugía MVS
City
MExico
State/Province
D.f.
ZIP/Postal Code
14269
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
33860531
Citation
Maguire MJ, Marson AG, Nevitt SJ. Antidepressants for people with epilepsy and depression. Cochrane Database Syst Rev. 2021 Apr 16;4(4):CD010682. doi: 10.1002/14651858.CD010682.pub3.
Results Reference
derived

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

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