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The purpose of this study is to evaluate clinical efficacy (affective and cognitive) in patients with moderate depression between TMS over the left Dorsolateral Prefrontal Cortex (DLPFC) with simulated TMS, as well as clinical response when 5 sessions / week are applied vs. 2 sessions / week. All patients will receive 15 TMS sessions as initial treatment (active or sham) and respondents will participate in an TMS follow-up on the left DLPFC for three months.
This is a randomized, double-blinded, placebo-controlled, parallel group clinical trial to evaluate the efficacy of two Transcranial Magnetic Stimulation (TMS) protocols in patients with major depressive disorder (MDD). 70 ambulatory patients with a MDD diagnosis from the Clinic at the Department of Psychiatry and Mental Health at the Universidad Nacional Autónoma de México (UNAM) will be included. All Patients will complete a total of 15 sessions of treatment in any of four groups: A group of patients will be randomly assigned to receive either 5 active TMS sessions or 2 sessions per week. Sham controls will also be randomly assigned to receive either 5 TMS sessions or 2 sessions per week. Afterwards, all participants will receive 2 sessions per month for a 3 month period. Depressive and anxiety symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment phase, and once at the end of a 3-month follow up. In addition, neuropsychological evaluations will be applied at baseline and at the end of the 15 session's treatment. Sessions will be applied with a MAG pro x 100 transcranial magnetic stimulator. Motor threshold will be set. Sessions will be applied over the left DLPFC at 5 Hz, 30 trains, 100%. Categorical variables will be described by percentages and frequencies. Continuous variables will be described by means and standard deviations. Treatment groups will be compared using Student's T test. Cognitive, anxiety and depressive symptom scale scores between treatment groups will be compared using repeated measures ANOVA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial magnetic stimulation | Sham Comparator | Sham repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions. |
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| Transcraneal magnetic stimulation | Active Comparator | Active repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions. |
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| Sham Comparator | Sham Comparator | Sham repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions. |
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| Active Comparator | Active Comparator | Active repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Total scores on the Hamilton depression scale depression | After 15 sessions of treatment and at 3 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Performance on the Wisconsin card sorting test | After 15 sessions of treatment and at 3 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Performance on stop signal task | After 15 sessions of treatment and at 3 months follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Armas-Castañeda, MD | Contact | +525556228222 | 43139 | drgaba1@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Mental Health, Faculty of Medicine, UNAM | Recruiting | Mexico City | Mexico City | 04510 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Unable to connect to PubMed to validate , last attempt on May 29, 2014 at 3:25 PM EDT | ||
| 34718252 | Derived | Armas-Castaneda G, Ricardo-Garcell J, Reyes JV, Heinze G, Salin RJ, Gonzalez JJ. Two rTMS sessions per week: a practical approach for treating major depressive disorder. Neuroreport. 2021 Dec 8;32(17):1364-1369. doi: 10.1097/WNR.0000000000001737. Epub 2021 Oct 28. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Sham Transcranial Magnetic Stimulation | Device |
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| D019965 |
| Neurocognitive Disorders |