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Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients

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ClinicalTrials.gov Identifier: NCT02213016
Recruitment Status : Unknown
Verified August 2014 by Gabriela Armas Castañeda, Universidad Nacional Autonoma de Mexico.
Recruitment status was:  Recruiting
First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Gabriela Armas Castañeda, Universidad Nacional Autonoma de Mexico

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.

Condition or disease Intervention/treatment Phase
Major Depression Device: Transcranial Magnetic Stimulation Device: Sham Transcranial Magnetic Stimulation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation on Cognitive, Anxiety and Depressive Symptoms in Patients Diagnosed With Major Depressive Disorder
Study Start Date : September 2013
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: TMS device MagVenture model MagPro 100




Primary Outcome Measures :
  1. Total scores on the Hamilton depression scale depression [ Time Frame: After 15 sessions of treatment and at 3 months follow up ]

Secondary Outcome Measures :
  1. Performance on the Wisconsin card sorting test [ Time Frame: After 15 sessions of treatment and at 3 months follow-up ]

Other Outcome Measures:
  1. Performance on stop signal task [ Time Frame: After 15 sessions of treatment and at 3 months follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213016


Contacts
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Contact: Gabriela Armas-Castañeda, MD +525556228222 ext 43139 drgaba1@gmail.com

Locations
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Mexico
Department of Psychiatry and Mental Health, Faculty of Medicine, UNAM Recruiting
Mexico, Mexico City, Mexico, 04510
Contact: Gabriela Armas, MD    +5255 56228222 ext 43139    drgaba1@gmail.com   
Contact: Francisco Romo, MD    +5255 56228222 ext 43137    franciscoromo@yahoo.com   
Principal Investigator: Gabriela Armas, MD         
Sponsors and Collaborators
Universidad Nacional Autonoma de Mexico

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

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Responsible Party: Gabriela Armas Castañeda, Technical academic, Universidad Nacional Autonoma de Mexico
ClinicalTrials.gov Identifier: NCT02213016     History of Changes
Other Study ID Numbers: 141-2011
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014

Keywords provided by Gabriela Armas Castañeda, Universidad Nacional Autonoma de Mexico:
Stimulation magnetic transcranial, major depression, cognitive impairment

Additional relevant MeSH terms:
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Depression
Depressive Disorder, Major
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders