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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)

Primary Purpose

DEPRESSION

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DEPRESSION

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High Frequency Left repetitive

intermittent Theta Burst Stimulation (iTBS)

Arm Description

High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100

intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Relapse rate
Quality of life
Measures of cortical excitability

Full Information

First Posted
February 17, 2015
Last Updated
July 3, 2019
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02376491
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DEPRESSION

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Frequency Left repetitive
Arm Type
Active Comparator
Arm Description
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100
Arm Title
intermittent Theta Burst Stimulation (iTBS)
Arm Type
Experimental
Arm Description
intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks Magventure Cool B65 Coil with Magpro X100
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
Therapeutic response rate
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Relapse rate
Time Frame
6 months
Title
Quality of life
Time Frame
6 months
Title
Measures of cortical excitability
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Bulteau, dr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28086851
Citation
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.
Results Reference
derived

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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

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