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

Depression Clinical Trial

— CBTvsSSRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262156
• Other study ID #: 49/06
• Secondary ID: U1111-1158-3147
• Status: Completed
• Phase: N/A
• First received: October 7, 2014
• Last updated: March 27, 2015
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• Source: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Epilepsy
• Epilepsy, Temporal Lobe

Intervention

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

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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Neurología y Neurocirugía MVS	MExico	D.f.

Sponsors (1)

Lead Sponsor	Collaborator
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Beck Depression Inventory score		baseline, 6 weeks and 12 weeks	No
Secondary	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	baseline, 6 weeks and 12 weeks	No
Secondary	Hospital anxiety and depression scale (HADS)	the HADS measures severity of symptoms of anxiety and depression. Lower scores indicates less symptoms	baseline, 4weeks and 12 weeks	No