Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients

Major Depression Clinical Trial

Official title:

Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation on Cognitive, Anxiety and Depressive Symptoms in Patients Diagnosed With Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02213016
• Other study ID #: 141-2011
• Status: Recruiting
• Phase: Phase 4
• First received: August 7, 2014
• Last updated: August 8, 2014
• Start date: September 2013
• Est. completion date: February 2017

Study information

• Verified date: August 2014
• Source: Universidad Nacional Autonoma de Mexico
• Contact: Gabriela Armas-Castañeda, MD
• Phone: +525556228222
• Email: drgaba1[@]gmail.com
• Is FDA regulated: No
• Health authority: Mexico: Institutional Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression

Intervention

Device:
• Transcranial Magnetic Stimulation

• Sham Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
Mexico	Department of Psychiatry and Mental Health, Faculty of Medicine, UNAM	Mexico	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Unable to connect to PubMed to validate , last attempt on May 29, 2014 at 3:25 PM EDT

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Performance on stop signal task		After 15 sessions of treatment and at 3 months follow-up	No
Primary	Total scores on the Hamilton depression scale depression		After 15 sessions of treatment and at 3 months follow up	No
Secondary	Performance on the Wisconsin card sorting test		After 15 sessions of treatment and at 3 months follow-up	No