NCT02754375

Brief Summary

Biological markers of depressive states have been studied, but their usefulness to predict the therapeutic response is unknown. This issue is major in all depressive states which have not remitted after several lines of treatment. rTMS (repetitive transcranial magnetic stimulation) is a non-pharmacological alternative in the treatment of depression, but its effects on cerebral functioning are not known in episodes which have resist to conventional treatments. The investigators will include 50 depressive patients who have failed to respond to two successive antidepressant medication, and propose them a treatment with low frequency rTMS during 3 to 6 weeks. Cerebral functional imaging with 18FDG-PET (positon emission tomography) with be assessed at the beginning and at the end of rTMS acute treatment, in order to measure induced metabolic changes and their correlation with clinical states. Patients who have responded to rTMS acute treatment may continue this therapeutic for six months, and the investigators will assess if efficacy maintenance is related with cerebral metabolic variations

Trial Health

90
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable depression

Geographic Reach
2 countries

2 active sites

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

April 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

May 4, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

3.8 years

First QC Date

April 21, 2016

Last Update Submit

April 11, 2022

Conditions

Depression

Keywords

biological markersrTMS

Outcome Measures

Primary Outcomes (1)

  • Variation of the regional cerebral glucose consumption between the two PET-TDM

    Variation of the regional cerebral glucose consumption between the two PET-TDM (realized at inclusion and at Week 6)

    at week 6

Secondary Outcomes (1)

  • Comparison of local glucose use between responder and non-responder patients

    at week 6

Study Arms (1)

Patient

EXPERIMENTAL

Patient with resistant depression treated with rTMS

Procedure: rTMS

Interventions

rTMSPROCEDURE
Patient

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject from 40 to 65 years old
  • Characterized current depressive Episode, unipolar, without psychotic characteristic (according to DSM IV-TR)
  • Absence of answer or partial clinical answer to more than two antidepressant treatments of different therapeutic classes to effective posology on a duration of at least 6 weeks
  • Patient affiliated to French social security
  • Patient must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations

You may not qualify if:

  • Failure in a previous low-frequency rTMS cure (at least 15 sessions)
  • Failure in a cure of bilateral ECT (at least 8 sessions) or unilateral (at least 10 sessions)
  • Mental disorder owed to a general medical affection ( DSM-IV)
  • Severe or not stabilized somatic Disease
  • chronic depression evolving for more than 3 years
  • Not answer in more of therapeutic antidepressive five well (documented) conducts
  • Presence of contraindication the SMTr, of which epileptic disease
  • Schizophrenic Disorder
  • Addicting Disorder with current dependence (alcohol, cannabis, benzodiazepin)
  • Bipolar disorder (I, II)
  • Disorder of personality to cluster A and B co-morbid
  • Pregnant Woman (dosage of urinary Beta-HCG)
  • Vulnerable Person: major under guardianship or guardianship, minor
  • Mental Deficiency of the subject making its participation on approval impossible
  • Participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Nice

Nice, 06000, France

Location

Hôpital Princesse Grace

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2016

First Posted

April 28, 2016

Study Start

May 4, 2016

Primary Completion

February 6, 2020

Study Completion

March 20, 2020

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)FR(1)