Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients
Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation on Cognitive, Anxiety and Depressive Symptoms in Patients Diagnosed With Major Depressive Disorder
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 7, 2014
CompletedFirst Posted
Study publicly available on registry
August 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 11, 2014
August 1, 2014
3 years
August 7, 2014
August 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total scores on the Hamilton depression scale depression
After 15 sessions of treatment and at 3 months follow up
Secondary Outcomes (1)
Performance on the Wisconsin card sorting test
After 15 sessions of treatment and at 3 months follow-up
Other Outcomes (1)
Performance on stop signal task
After 15 sessions of treatment and at 3 months follow-up
Study Arms (4)
Transcranial magnetic stimulation
SHAM COMPARATORSham repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.
Transcraneal magnetic stimulation
ACTIVE COMPARATORActive repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions.
Sham Comparator
SHAM COMPARATORSham repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.
Active Comparator
ACTIVE COMPARATORActive repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Epilepsy or seizure risk record
- Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry and Mental Health, Faculty of Medicine, UNAM
Mexico City, Mexico City, 04510, Mexico
Related Publications (2)
Unable to connect to PubMed to validate , last attempt on May 29, 2014 at 3:25 PM EDT
BACKGROUNDArmas-Castaneda G, Ricardo-Garcell J, Reyes JV, Heinze G, Salin RJ, Gonzalez JJ. Two rTMS sessions per week: a practical approach for treating major depressive disorder. Neuroreport. 2021 Dec 8;32(17):1364-1369. doi: 10.1097/WNR.0000000000001737. Epub 2021 Oct 28.
PMID: 34718252DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Technical academic
Study Record Dates
First Submitted
August 7, 2014
First Posted
August 11, 2014
Study Start
September 1, 2013
Primary Completion
September 1, 2016
Study Completion
February 1, 2017
Last Updated
August 11, 2014
Record last verified: 2014-08