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
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D.f.
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MExico, D.f., Mexico, 14269
- Instituto Nacional de Neurologia Y Neurocirugia Mvs
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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 |
|---|---|
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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. |
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:
|
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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.
|
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:
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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
|
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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
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baseline, 4weeks and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epileptic Syndromes
- Mood Disorders
- Epilepsies, Partial
- Epilepsy
- Depression
- Depressive Disorder
- Epilepsy, Temporal Lobe
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Serotonin Receptor Agonists
- Serotonin
- Antidepressive Agents
- Serotonin Uptake Inhibitors
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.