|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
7 April 2015 |
|
Main ID: |
NCT02262156 |
|
Date of registration:
|
07/10/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients
CBTvsSSRI |
|
Scientific title:
|
Treatment Of Depression In Patients With Temporal Lobe Epilepsy: Comparative Study Of Cognitive Behavioral Therapy Vs. Selective Serotonin Reuptake Inhibitors |
|
Date of first enrolment:
|
August 2014 |
|
Target sample size:
|
15 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT02262156 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Mexico
| | | | | | | |
|
Contacts
|
|
Name:
|
Daniel Crail-Melendez, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Depression
|
|
Epilepsy, Temporal Lobe
|
|
Intervention(s)
|
|
Drug: SSRI
|
|
Other: Cognitive behavioral therapy
|
|
Primary Outcome(s)
|
|
Change in Beck Depression Inventory score
[Time Frame: baseline, 6 weeks and 12 weeks]
|
|
Secondary Outcome(s)
|
|
Quality of Life in Epilepsy Scale
[Time Frame: baseline, 6 weeks and 12 weeks]
|
|
Hospital anxiety and depression scale (HADS)
[Time Frame: baseline, 4weeks and 12 weeks]
|
|
Secondary ID(s)
|
|
49/06
|
|
U1111-1158-3147
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|