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

NCT ID: NCT02262156

Last Updated: 2015-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-11-30

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.

Conditions

Depression; Epilepsy, Temporal Lobe

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

SSRI

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

CBT; selective serotonin reuptake inhibitor; antidepressant

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

OTHER

Sponsor Role: lead

Responsible Party

Edgar Daniel Crail Melendez

Md

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Crail-Melendez, MD

Role: PRINCIPAL_INVESTIGATOR

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Locations

Instituto Nacional de Neurología y Neurocirugía MVS

México, D.f., Mexico

Countries

Mexico

References

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.

Reference Type: DERIVED

PMID: 33860531 (View on PubMed)

Other Identifiers

U1111-1158-3147

Identifier Type: OTHER

Identifier Source: secondary_id

49/06

Identifier Type: -

Identifier Source: org_study_id