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Clinical Trials/NCT02213016
NCT02213016UnknownPhase 4

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

Universidad Nacional Autonoma de Mexico2 sites in 1 country80 target enrollmentStarted: September 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
80
Locations
2
Primary Endpoint
Total scores on the Hamilton depression scale depression

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts 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

Arms & Interventions

Transcraneal magnetic stimulation

Active Comparator

Active repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.

Intervention: Transcranial Magnetic Stimulation (Device)

Sham Comparator

Sham Comparator

Sham repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.

Intervention: Sham Transcranial Magnetic Stimulation (Device)

Active Comparator

Active Comparator

Active repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.

Intervention: Transcranial Magnetic Stimulation (Device)

Transcranial magnetic stimulation

Sham Comparator

Sham repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.

Intervention: Sham Transcranial Magnetic Stimulation (Device)

Outcomes

Primary Outcomes

Total scores on the Hamilton depression scale depression

Time Frame: After 15 sessions of treatment and at 3 months follow up

Secondary Outcomes

  • Performance on the Wisconsin card sorting test(After 15 sessions of treatment and at 3 months follow-up)

Investigators

Sponsor
Universidad Nacional Autonoma de Mexico
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gabriela Armas Castañeda

Technical academic

Universidad Nacional Autonoma de Mexico

Study Sites (2)

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