Major Depression
Conditions
Keywords
Stimulation magnetic transcranial, major depression, cognitive impairment
Brief summary
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.
Detailed description
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.
Interventions
DEVICETranscranial Magnetic Stimulation
DEVICESham Transcranial Magnetic Stimulation
Sponsors
Universidad Nacional Autonoma de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of major depressive disorder * Having a greater or equal score to 18 points in the Ham-D scale at the moment of the initial evaluation * Treatment free patients
Exclusion criteria
* Epilepsy or seizure risk record * Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total scores on the Hamilton depression scale depression | After 15 sessions of treatment and at 3 months follow up |
Secondary
| Measure | Time frame |
|---|---|
| Performance on the Wisconsin card sorting test | After 15 sessions of treatment and at 3 months follow-up |
Other
| Measure | Time frame |
|---|---|
| Performance on stop signal task | After 15 sessions of treatment and at 3 months follow-up |
Countries
Mexico
Contacts
Primary ContactGabriela Armas-Castañeda, MD
Outcome results
None listed