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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 (THETA-DEP)

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ClinicalTrials.gov Identifier: NCT02376491
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
This trial will compare innovating stimulation parameters, intermittent Theta Burst Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both treatment conditions. The study seeks to determine if there is a superiority in therapeutic efficacy with iTBS protocol compared to conventional one.

Condition or disease Intervention/treatment Phase
DEPRESSION Device: Transcranial magnetic stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2015
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Device: Transcranial magnetic stimulation
Experimental: intermittent Theta Burst Stimulation (iTBS)
intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100
Device: Transcranial magnetic stimulation



Primary Outcome Measures :
  1. Therapeutic response rate [ Time Frame: 6 months ]

    Primary outcome will be therapeutic response rate corresponding to with MADRS score improvement > 50 % in each group at the end of TMS sessions and one month after.

    A final score of <8 is categorized as remission.



Secondary Outcome Measures :
  1. Relapse rate [ Time Frame: 6 months ]
  2. Quality of life [ Time Frame: 6 months ]
  3. Measures of cortical excitability [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years to 75 years
  • 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:

  • Initiation or modification of antidepressant drug
  • 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

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): NCT02376491


Locations
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France
CHU de Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Samuel Bulteau, dr chu de Nantes
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02376491    
Other Study ID Numbers: RC14_0375
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders