NCT03701724

Brief Summary

Treatment resistant depression (TRD) is a frequent, debilitating condition mostly treated by antidepressants. Repeated magnetic transcranial stimulation (rTMS) has proven adjuvant efficacy in TRD in the acute phase of treatment with a very good tolerance and acceptability. Maintenance rTMS (mTMS) is a strategy consisting in adding regular single TMS sessions after response to an acute course in order to keep the benefit of initial treatment over several month or years. Demonstrating that rTMS is efficient to improve long-term prognosis and decrease economic burden would have a tremendous impact in clinical practice in psychiatry. Thus the investigator's aim is to analyze the long term impact of mTMS treatment on costs, but also quality of life and clinical issues.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

19 active sites

Status
unknown

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

September 17, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

November 5, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

4.1 years

First QC Date

September 17, 2018

Last Update Submit

September 15, 2022

Conditions

Treatment-resistant Depression

Keywords

Major Depressive DisorderUnipolar depressionChronic depressionRecurrent depressionDepressive disorderMagnetic stimulationNon-invasive brain stimulation1 Hertz (Hz) rTMSMaintenance rTMSCost-utilityEfficiencyMedico-economicAntidepressants

Outcome Measures

Primary Outcomes (1)

  • Cost-utility ratio, according to collective perspective of rTMS use in TRD compared to conventional therapeutic approaches without active rTMS.

    The utility will be measured by : Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 3 answers are possible. The costs will be measured by the addition of the following costs: Drugs dispensing via Health insurance database "National system of information of the French health insurance" (SNIIRAM), hospitalizations, work stoppages and care consumption collected in a declarative patient questionnaire.

    12 months

Secondary Outcomes (27)

  • Cost-utility ratio, according to collective perspective of rTMS use in TRD compared to conventional therapeutic approaches without active rTMS.

    24 months

  • Budget impact analysis of spreading the most efficient strategy for using rTMS (systematic mTMS or rTMS course in case of relapse).

    5 years

  • Major depressive disorder history

    Baseline

  • Level of depression treatment-resistance

    Baseline

  • professional status

    Baseline,12 months and 24 months

  • +22 more secondary outcomes

Study Arms (3)

Systematic maintenance rTMS (arm A)

EXPERIMENTAL

Active rTMS treatment followed, for responders, by systematic maintenance rTMS Depression usual medical treatment (psychosocial approach and/or pharmacotherapy and/or, ECT…)

Device: Systematic maintenance rTMS

rTMS course in case of relapse (arm B)

EXPERIMENTAL

Active rTMS treatment followed, for responders, by additional rTMS courses, in case of relapse Depression usual medical treatment (psychosocial approach and/or pharmacotherapy and/or, ECT…)

Device: rTMS course in case of relapse

Sham rTMS (arm C)

SHAM COMPARATOR

sham rTMS followed, for responders, by either systematic sham mTMS (50%) or additional sham rTMS course in case of relapse(50%) Depression usual medical treatment (psychosocial approach and/or pharmacotherapy and/or, ECT…)

Device: sham rTMS

Interventions

Systematic maintenance rTMSDEVICE

Same parameters as the initial course (session of 8,5 minutes, at 1 Hz, on the right dorsolateral prefrontal cortex (DLPFC) targeting with either neuronavigation or the Beam). The frequency is : 2 sessions / week during 1 month, then 1 session / week during 2 months and finally 1 session every 2 weeks during 8 months.

Systematic maintenance rTMS (arm A)
rTMS course in case of relapseDEVICE

Same parameters as the initial course. The frequency is the same as the initial course: one daily session on 5 consecutive working days from Monday to Friday for at least 20 to 30 sessions over 4 to 6 weeks.

rTMS course in case of relapse (arm B)
sham rTMSDEVICE

The sham stimulation consists of the identical rTMS procedure at the identical location using a commercial figure-eight sham coil. However, it does not produce the identical tactile sensation. A local electrical stimulation will be delivered with two disposable Electromyogram (EMG) electrodes using a transcutaneous electrical nerve stimulation (TENS) Stimulator.

Sham rTMS (arm C)

Eligibility Criteria

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

You may qualify if:

  • Major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 MADRS \>19
  • Episode duration: 12 weeks to 3 years.
  • to 4 unsuccessful treatment lines (including antidepressants, and potentialization agents lithium and quetiapine) despite adequate dosage and duration (6 weeks stable posology)
  • Ability to consent and express informed consent, to answer questionnaires and to go to follow-up visits.
  • Affiliation to social security

You may not qualify if:

  • Bipolar disorder
  • Schizophrenia and other psychotic disorders
  • Mental retardation or developmental disorder
  • Substance abuse or dependence
  • Depression symptoms better explained by medical conditions
  • Neurologic conditions (e.g.,previous epilepsy or unexplained seizures, stroke, trauma, infection, metabolic disease, severe migraines, multiple sclerosis, brain tumor)
  • Presence of at least one contra-indication to rTMS
  • Pregnancy/breast-feeding
  • Patient who previously received 5 lines or more pharmacological treatment for the current episode (excluding symptomatic psychotropic drugs, e.g. benzodiazepines and hypnotics)
  • Former use of electroconvulsive therapy or rTMS within the current episode.
  • Previous failure of adequate ECT (at least 12 well conducted sessions) or rTMS course (at least 20 well conducted sessions) in the medical history.
  • History of at least two courses of ECT, previous need for maintenance ECT.
  • Protection measure : maintenance of justice, tutelage, legal guardianship
  • Woman of childbearing age without effective contraception
  • Liberty deprivation (e.g. incarceration, therapeutic injunction)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

CHU d'Angers

Angers, 49100, France

Location

CHRU de Besançon

Besançon, 25000, France

Location

CH le Vinatier Lyon

Bron, France

Location

CHU de Caen

Caen, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU de Dijon

Dijon, France

Location

Clinique de Vontes

Esvre-sur-Indre, France

Location

EPSM de Lille

Lille, France

Location

CH Esquirol - Limoges

Limoges, France

Location

CHU de Montpellier

Montpellier, France

Location

Nantes University Hospital

Nantes, 44000, France

Location

EPS de Ville-Evrard

Neuilly-sur-Marne, France

Location

GH PItié Salpétrière

Paris, France

Location

GHU Psychiatrie Ste Anne

Paris, France

Location

CH Henri Laborit (Poitiers)

Poitiers, 86000, France

Location

Centre hospitalier Guillaume Regnier Rennes

Rennes, 35000, France

Location

CH du Rouvray - Rouen

Rouen, France

Location

CHU de Toulouse

Toulouse, France

Location

CHU de Tours / CHRU de Tours

Tours, 37540, France

Location

Related Publications (1)

  • Bulteau S, Laurin A, Volteau C, Dert C, Lagalice L, Schirr-Bonnans S, Bukowski N, Guitteny M, Simons L, Cabelguen C, Pichot A, Tessier F, Bonnin A, Lepage A; ACOUSTIM Investigators Group; HUGOPSY Network; Vanelle JM, Sauvaget A, Riche VP. Cost-utility analysis of curative and maintenance repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant unipolar depression: a randomized controlled trial protocol. Trials. 2020 Apr 5;21(1):312. doi: 10.1186/s13063-020-04255-9.

    PMID: 32248820DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantDepressive Disorder, MajorDepressive DisorderDepression

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Samuel Bulteau, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Sham rTMS will be used for the arm "without rTMS"
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

October 10, 2018

Study Start

November 5, 2018

Primary Completion

December 15, 2022

Study Completion

December 30, 2023

Last Updated

September 16, 2022

Record last verified: 2022-09

Locations

FR(19)