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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1158-3147 | Other Identifier | WHO UTN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beck Depression Inventory score | baseline, 6 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hospital anxiety and depression scale (HADS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Crail-Melendez, MD | El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de NeurologÃa y NeurocirugÃa MVS | México | D.f. | 14269 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33860531 | Derived | 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. |
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| 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. |
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the HADS measures severity of symptoms of anxiety and depression. Lower scores indicates less symptoms |
| baseline, 4weeks and 12 weeks |
| ID | Term |
|---|---|
| D003863 | Depression |
| D004833 | Epilepsy, Temporal Lobe |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D004828 | Epilepsies, Partial |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D017367 | Selective Serotonin Reuptake Inhibitors |
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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