<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02262156</url>
  </required_header>
  <id_info>
    <org_study_id>49/06</org_study_id>
    <secondary_id>U1111-1158-3147</secondary_id>
    <nct_id>NCT02262156</nct_id>
  </id_info>
  <brief_title>CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients</brief_title>
  <acronym>CBTvsSSRI</acronym>
  <official_title>Treatment Of Depression In Patients With Temporal Lobe Epilepsy: Comparative Study Of Cognitive Behavioral Therapy Vs. Selective Serotonin Reuptake Inhibitors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to compare the effect of group-cognitive-behavioral therapy&#xD;
      (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline, in&#xD;
      patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      patients with temporal lobe epilepsy and depression will be enrolled into one of two&#xD;
      treatment modality. The first group will receive 12 group cognitive behavioral sessions. CBT&#xD;
      is a psychotherapy focused on the recognition and change of distorted thoughts and&#xD;
      maladaptive behaviors.&#xD;
&#xD;
      The second group will receive treatment with the selective serotonin reuptake inhibitor&#xD;
      sertraline or citalopram for 12 weeks. This antidepressant is wide used to treat depression&#xD;
      in patients with TLE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Beck Depression Inventory score</measure>
    <time_frame>baseline, 6 weeks and 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life in Epilepsy Scale</measure>
    <time_frame>baseline, 6 weeks and 12 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital anxiety and depression scale (HADS)</measure>
    <time_frame>baseline, 4weeks and 12 weeks</time_frame>
    <description>the HADS measures severity of symptoms of anxiety and depression. Lower scores indicates less symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Depression</condition>
  <condition>Epilepsy, Temporal Lobe</condition>
  <arm_group>
    <arm_group_label>Cognitive behavioral Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CBT program to be used in group modality that focused on managing symptoms of depression in patients with epilepsy.&#xD;
12 CBT sessions, consisting of one weekly 90-minute session for 12 consecutive weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selective serotonin euptake inhibitor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive behavioral therapy</intervention_name>
    <description>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.&#xD;
The CBT structure include psychoeducation, addressing dysfunctional thoughts and maladaptive behaviors; problem solving techniques, assertiveness, coping strategies and depression relapse prevention</description>
    <arm_group_label>Cognitive behavioral Therapy</arm_group_label>
    <other_name>CBT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SSRI</intervention_name>
    <description>Patients will receive the &quot;treatment as usual&quot; 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.</description>
    <arm_group_label>Selective serotonin euptake inhibitor</arm_group_label>
    <other_name>selective serotonin reuptake inhibitor</other_name>
    <other_name>antidepressant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With Major depressive disorder according to criteria from the fourth edition of the&#xD;
             Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)&#xD;
&#xD;
          -  Diagnosed with TLE according to the criteria of the International League Against&#xD;
             Epilepsy&#xD;
&#xD;
          -  Literates had sign an informed consent&#xD;
&#xD;
          -  Patients on antidepressant treatments will be allowed to participate only if they had&#xD;
             been at stable doses for more than 8 weeks and still show signs of significant&#xD;
             depression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with high risk of suicide who required hospitalization&#xD;
&#xD;
          -  Patients who abused or are dependent on drugs&#xD;
&#xD;
          -  Those with a history of head trauma six months prior to the interview&#xD;
&#xD;
          -  Patients who have any condition that would prevent them from understanding the study&#xD;
             or the psychotherapeutic process, such as mental retardation, psychosis, delirium,&#xD;
             dementia, etc&#xD;
&#xD;
          -  Patients who have previously received CBT&#xD;
&#xD;
          -  Patients who have started, an antidepressant drug the last 8 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Crail-Melendez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Neurología y Neurocirugía MVS</name>
      <address>
        <city>MExico</city>
        <state>D.f.</state>
        <zip>14269</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>March 27, 2015</last_update_submitted>
  <last_update_submitted_qc>March 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez</investigator_affiliation>
    <investigator_full_name>Edgar Daniel Crail Melendez</investigator_full_name>
    <investigator_title>Md</investigator_title>
  </responsible_party>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>Selective serotonin reuptake inhibitor</keyword>
  <keyword>depression</keyword>
  <keyword>epilepsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Epilepsy, Temporal Lobe</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antidepressive Agents</mesh_term>
    <mesh_term>Serotonin</mesh_term>
    <mesh_term>Selective Serotonin Reuptake Inhibitors</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02262156
org study id: 49/06
secondary id: U1111-1158-3147
nct id: NCT02262156
lead sponsor: 
has dmc: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Beck Depression Inventory score
time frame: baseline, 6 weeks and 12 weeks
measure: Quality of Life in Epilepsy Scale
time frame: baseline, 6 weeks and 12 weeks
description: 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
measure: Hospital anxiety and depression scale (HADS)
time frame: baseline, 4weeks and 12 weeks
description: the HADS measures severity of symptoms of anxiety and depression. Lower scores indicates less symptoms
arm group label: Cognitive behavioral Therapy
arm group type: Experimental
description: 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.
arm group label: Selective serotonin euptake inhibitor
arm group type: Active Comparator
description: Patients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria.
intervention type: Other
intervention name: Cognitive behavioral therapy
description: 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
arm group label: Cognitive behavioral Therapy
other name: CBT
intervention type: Drug
intervention name: SSRI
description: 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.
arm group label: Selective serotonin euptake inhibitor
other name: selective serotonin reuptake inhibitor
other name: antidepressant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Daniel Crail-Melendez, MD
role: Principal Investigator
affiliation: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
investigator full name: Edgar Daniel Crail Melendez
investigator title: Md
mesh term: Epilepsy
mesh term: Epilepsy, Temporal Lobe
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Antidepressive Agents
mesh term: Serotonin
mesh term: Selective Serotonin Reuptake Inhibitors