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

DEPRESSION Clinical Trial

— THETA-DEP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376491
• Other study ID #: RC14_0375
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 2019

Study information

• Verified date: June 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• DEPRESSION
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Device:
• Transcranial magnetic stimulation

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic response rate	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.	6 months
Secondary	Relapse rate		6 months
Secondary	Quality of life		6 months
Secondary	Measures of cortical excitability		6 months