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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02262156
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : March 30, 2015
Information provided by (Responsible Party):
Edgar Daniel Crail Melendez, 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.

Condition or disease Intervention/treatment Phase
Depression Epilepsy, Temporal Lobe Other: Cognitive behavioral therapy Drug: SSRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Of Depression In Patients With Temporal Lobe Epilepsy: Comparative Study Of Cognitive Behavioral Therapy Vs. Selective Serotonin Reuptake Inhibitors
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Serotonin

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 Name: 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

Primary Outcome Measures :
  1. Change in Beck Depression Inventory score [ Time Frame: baseline, 6 weeks and 12 weeks ]

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02262156

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Instituto Nacional de Neurología y Neurocirugía MVS
MExico, D.f., Mexico, 14269
Sponsors and Collaborators
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
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Principal Investigator: Daniel Crail-Melendez, MD El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

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Responsible Party: Edgar Daniel Crail Melendez, Md, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez Identifier: NCT02262156    
Other Study ID Numbers: 49/06
U1111-1158-3147 ( Other Identifier: WHO UTN )
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: October 2014
Keywords provided by Edgar Daniel Crail Melendez, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez:
Cognitive Behavioral Therapy
Selective serotonin reuptake inhibitor
Additional relevant MeSH terms:
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Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Uptake Inhibitors
Epilepsy, Temporal Lobe
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Epileptic Syndromes
Antidepressive Agents
Psychotropic Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Membrane Transport Modulators