Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients

August 8, 2014 updated by: Gabriela Armas Castañeda, Universidad Nacional Autonoma de Mexico

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gabriela Armas-Castañeda, MD
  • Phone Number: 43139 +525556228222
  • Email: drgaba1@gmail.com

Study Locations

  • Mexico
    • Mexico City
      • Mexico, Mexico City, Mexico, 04510
        • Recruiting
        • Department of Psychiatry and Mental Health, Faculty of Medicine, UNAM
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriela Armas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Transcranial magnetic stimulation
Sham repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.
Device: Sham Transcranial Magnetic Stimulation
Other Names:
  • TMS device Magventure, model MagPro 100. COIL COOL-B65.
Active Comparator: Transcraneal magnetic stimulation
Active repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.
Device: Transcranial Magnetic Stimulation
Other Names:
  • TMS device MagVenture model MagPro 100
Sham Comparator: Sham Comparator
Sham repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.
Device: Sham Transcranial Magnetic Stimulation
Other Names:
  • TMS device Magventure, model MagPro 100. COIL COOL-B65.
Active Comparator: Active Comparator
Active repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.
Device: Transcranial Magnetic Stimulation
Other Names:
  • TMS device MagVenture model MagPro 100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total scores on the Hamilton depression scale depression
Time Frame: After 15 sessions of treatment and at 3 months follow up
After 15 sessions of treatment and at 3 months follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Performance on the Wisconsin card sorting test
Time Frame: After 15 sessions of treatment and at 3 months follow-up
After 15 sessions of treatment and at 3 months follow-up

Other Outcome Measures

Outcome Measure
Time Frame
Performance on stop signal task
Time Frame: After 15 sessions of treatment and at 3 months follow-up
After 15 sessions of treatment and at 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional Autonoma de Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 8, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Estimate)

August 11, 2014

Last Update Submitted That Met QC Criteria

August 8, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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