CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients (CBTvsSSRI)
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|ClinicalTrials.gov Identifier: NCT02262156|
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : March 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Depression Epilepsy, Temporal Lobe||Other: Cognitive behavioral therapy Drug: SSRI||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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.
- Change in Beck Depression Inventory score [ Time Frame: baseline, 6 weeks and 12 weeks ]
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02262156
|Instituto Nacional de Neurología y Neurocirugía MVS|
|MExico, D.f., Mexico, 14269|
|Principal Investigator:||Daniel Crail-Melendez, MD||El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez|