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

NCT02262156 | Completed

• 2 other identifiers: 49/06U1111-1158-3147
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Epilepsy, Temporal Lobe

Keywords

Cognitive Behavioral Therapy; Selective serotonin reuptake inhibitor; depression; epilepsy

Outcome Measures

Primary Outcomes (1)

• Change in Beck Depression Inventory score

  baseline, 6 weeks and 12 weeks

Secondary Outcomes (2)

• Quality of Life in Epilepsy Scale

  baseline, 6 weeks and 12 weeks

• Hospital anxiety and depression scale (HADS)

  baseline, 4weeks and 12 weeks

Study Arms (2)

Cognitive behavioral Therapy

EXPERIMENTAL

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

Selective serotonin euptake inhibitor

ACTIVE COMPARATOR

Patients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria.

Drug: SSRI

Interventions

Cognitive behavioral therapy 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

Also known as: CBT

Cognitive behavioral Therapy

SSRI 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.

Also known as: selective serotonin reuptake inhibitor, antidepressant

Selective serotonin euptake inhibitor

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez: lead

Study Sites (1)

Instituto Nacional de Neurología y Neurocirugía MVS

México, D.f., 14269, Mexico

Location

Related Publications (1)

• 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.

  PMID: 33860531 DERIVED

MeSH Terms

Conditions

Depression; Epilepsy, Temporal Lobe; Epilepsy

Interventions

Cognitive Behavioral Therapy; Selective Serotonin Reuptake Inhibitors; Antidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Daniel Crail-Melendez, MD

  El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 10, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 30, 2015

Record last verified: 2014-10

Locations

ME (1)