NCT02376491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 5, 2019

Status Verified

June 1, 2019

Enrollment Period

3.8 years

First QC Date

February 17, 2015

Last Update Submit

July 3, 2019

Conditions

DEPRESSION

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Relapse rate

    6 months

  • Quality of life

    6 months

  • Measures of cortical excitability

    6 months

Study Arms (2)

High Frequency Left repetitive

ACTIVE COMPARATOR

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

intermittent Theta Burst Stimulation (iTBS)

EXPERIMENTAL

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

Device: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulationDEVICE
High Frequency Left repetitiveintermittent Theta Burst Stimulation (iTBS)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

Related Publications (1)

  • 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.

    PMID: 28086851DERIVED

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Samuel Bulteau, dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 3, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

July 5, 2019

Record last verified: 2019-06

Locations

FR(1)