Efficacy of Intermittent ThetaBurst Stimulation Compared to 10 Hz Stimulation on Dorsolateral Prefrontal Cortex in Treatment Resistant Major Depressive Disorder: a Double-blind Randomized Study
NCT ID: NCT02376491
Last Updated: 2019-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-06-30
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High Frequency Left repetitive
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100
Transcranial magnetic stimulation
intermittent Theta Burst Stimulation (iTBS)
intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100
Transcranial magnetic stimulation
Interventions
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Transcranial magnetic stimulation
Eligibility Criteria
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Inclusion Criteria
* Both gender eligible
* Volontary and able to give consent
* Major depressive episode (MADRS \> 20) single or recurrent
* Resistance to at least 2 antidepressants ,
* Treated by antidepressant at efficient stable posology since more than 6 weeks
Exclusion Criteria
* Neurodegenerative diseas
* Bipolar I, II disorder
* Schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
* Substance abuse in past 15 days
* Substance dependence not weaned
* Benzodiazepine and any anticonvulsant during rTMS treatment course
* ECT failure in medical history
* Contra-indication to rTMS and MRI
* Pregnancy
* Difficulty to obtain informed consent
18 Years
75 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Samuel Bulteau, dr
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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CHU de Nantes
Nantes, , France
Countries
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References
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Bulteau S, Sebille V, Fayet G, Thomas-Ollivier V, Deschamps T, Bonnin-Rivalland A, Laforgue E, Pichot A, Valriviere P, Auffray-Calvier E, Fortin J, Pereon Y, Vanelle JM, Sauvaget A. Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial. Trials. 2017 Jan 13;18(1):17. doi: 10.1186/s13063-016-1764-8.
Other Identifiers
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RC14_0375
Identifier Type: -
Identifier Source: org_study_id
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