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Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression (ACOUSTIM)

Primary Purpose

Treatment-resistant Depression

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Systematic maintenance rTMS
rTMS course in case of relapse
sham rTMS
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Treatment-resistant Depression focused on measuring Major Depressive Disorder, Unipolar depression, Chronic depression, Recurrent depression, Depressive disorder, Magnetic stimulation, Non-invasive brain stimulation, 1 Hertz (Hz) rTMS, Maintenance rTMS, Cost-utility, Efficiency, Medico-economic, Antidepressants

Eligibility Criteria

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

Inclusion Criteria:

  • Major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 MADRS >19
  • Episode duration: 12 weeks to 3 years.
  • 2 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • CHU d'Angers
  • CHRU de Besançon
  • CH le Vinatier Lyon
  • CHU de Caen
  • CHU de Clermont-Ferrand
  • CHU de Dijon
  • Clinique de Vontes
  • EPSM de Lille
  • CH Esquirol - Limoges
  • CHU de Montpellier
  • Nantes University Hospital
  • EPS de Ville-Evrard
  • GH PItié Salpétrière
  • GHU Psychiatrie Ste Anne
  • CH Henri Laborit (Poitiers)
  • Centre hospitalier Guillaume Regnier Rennes
  • CH du Rouvray - Rouen
  • CHU de Toulouse
  • CHU de Tours / CHRU de Tours

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Systematic maintenance rTMS (arm A)

rTMS course in case of relapse (arm B)

Sham rTMS (arm C)

Arm Description

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

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…)

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…)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cost-utility ratio, according to collective perspective of rTMS use in TRD compared to conventional therapeutic approaches without active rTMS.
Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D) health-related quality of life questionnaire The costs will be measured by the additional of the following costs: Drugs dispensing via Health insurance database SNIIRAM, hospitalizations, work stoppages and care consumption collected in a declarative patient questionnaire
Budget impact analysis of spreading the most efficient strategy for using rTMS (systematic mTMS or rTMS course in case of relapse).
Comparison of intervention costs on the study sample and projection of these costs over 5 years, from the health insurance and hospital perspectives
Major depressive disorder history
This outcome will be assessed by patient interview, with the following data (not exhaustive): date of initial symptoms, length of the current episode, family antecedents of mood disorders.
Level of depression treatment-resistance
Maudsley Staging model score: a multidimensional tool to quantify treatment resistance in depression. It evaluates 5 dimensions: 1) length of the current depressive episode, 2) symptomatic intensity, 3) failure of the antidepressant drugs, 4) Increase treatment 5) use of Electro-convulsive therapy. The total score ranges from 3 to 15. 15 being the highest level of treatment resistance.
professional status
patient's professional status (active, unemployed, retired...)
marital status
patient's marital status (married, widow, single...)
Response rate
Response is defined as follows: decrease of the MADRS score by at least 50% compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score >34 being severe depression.
Remission rate
Remission is defined as follows: MADRS score ≤ 10 (see detailed description of MADRS in outcome 8)
Relapse-free survival
Number of patients with no relapse. Relapse is defined as follows: MADRS ≥ 20 (see detailed description of MADRS in outcome 8)
MADRS score
MADRS score (see detailed description of MADRS in outcome 8)
Beck Depression Inventory (BDI) score
The BDI is 13-item multiple-choice self-report inventory, for measuring the severity of depression. The global score is an addition of each item's score and ranges from 0 (minimal depression) to 39 (severe depression).
Clinical Global Impression (CGI) score
The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. Each scale is rated from 0 to 7. 0 being the best level and 7 the worst level.
Adverse events linked to the medical treatment for depression
Number and types of adverse events linked to the medical treatment for depression
Declarative drug compliance via the MARS (Medication Adherence Report Scale)
MARS is the Medication Adherence Report Scale, including 10 questions, the global score ranges from 0 to 10, 0 corresponds to the worst drug compliance and 10 to an excellent drug compliance
Declarative drug compliance via the CRS (Clinician Rating Scale)
CRS is the Clinician Rating Scale , including 7 questions, the global score ranges from 1 to 7, 7 being the worst level of drug compliance.
Treatment(s) switch(es)
Number of treatment switches per patient
Treatment(s) dose increase
Number of drug(s) dose(s) increases prescribed to the patient
Treatments combination(s)
List of drugs (name) prescribed to the patient
Rate of suicide attempts and suicides
number of suicide attempts and suicides per patient
Patient's quality of life
Short-Form 36 (SF 36) questionnaire: instrument used to assess multidimensional health-related quality of life, which measures 8 health related parameters: physical function, social function, physical role, emotional role, mental health, energy, pain, general health perceptions
Response rate at the end of rTMS courses
Response is defined as follows: decrease of the MADRS score by at least 50% compared to baseline score (see detailed description of MADRS in outcome 8)
Remission rate at the end of rTMS courses
Remission is defined as follows: MADRS score ≤ 10 (see detailed description of MADRS in outcome 8)
Number of days between the successive rTMS courses
Number of days between end of rTMS course X and beginning of course X+1, for each patient
Total number of rTMS sessions
total number of rTMS sessions per patient
Time between relapses
Number of days between relapses, per patient
Compliance with rTMS
number of missed sessions over the number of planned sessions, per patient
Patient acceptability of the rTMS technique: Analog Visual Scale
Analog Visual Scale of acceptability of the rTMS completed by the patient, ranging from 0 to 10. 0 being "not acceptable" and 10 being "totally acceptable"

Full Information

First Posted
September 17, 2018
Last Updated
September 15, 2022
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03701724
Brief Title
Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression
Acronym
ACOUSTIM
Official Title
Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
TRD is associated with enormous social, economic, and personal costs. In literature, psychosocial and pharmacological interventions showed limited one year long-term efficacy in terms of relapse (only 10% of sustained remission at one-year follow-up actually) and quality of life due to refractoriness, observance and adverse effects. In the recent years the field of non-invasive brain stimulation became more mature with an increasing level of evidence reaching Level 1 for rTMS as curative treatment for depression in international guidelines. It is a safe and well tolerated treatment but with still high relapse rate at 6 month and one year (comparable to those former described for ECT). mTMS is a promising tool (as it was proven for ECT) to achieve sustained response several month after treatment in a significant proportion of patients. Little is known about its long-term economic and social benefit which is a crucial question given its time consuming nature. To date there is no large Randomized Clinical Trial (RCT) assessing the long-term health economic interest or adjuvant mTMS compared to treatment as usual (TAU) alone in unipolar TRD . This study is a double-blind randomized controlled trial aiming at determining a 12 month cost-utility analysis, according to collective perspective, of two different modalities of rTMS (systematic mTMS or curative rTMS in case of relapse) for TRD compared to TAU alone. The secondary aims are to describe 24 month cost-utility, longitudinal clinical issues in terms of mood and quality of life, prognosis factors, as well as TAU actual strategies in that population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment-resistant Depression
Keywords
Major Depressive Disorder, Unipolar depression, Chronic depression, Recurrent depression, Depressive disorder, Magnetic stimulation, Non-invasive brain stimulation, 1 Hertz (Hz) rTMS, Maintenance rTMS, Cost-utility, Efficiency, Medico-economic, Antidepressants

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Sham rTMS will be used for the arm "without rTMS"
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Systematic maintenance rTMS (arm A)
Arm Type
Experimental
Arm Description
Active rTMS treatment followed, for responders, by systematic maintenance rTMS Depression usual medical treatment (psychosocial approach and/or pharmacotherapy and/or, ECT…)
Arm Title
rTMS course in case of relapse (arm B)
Arm Type
Experimental
Arm Description
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…)
Arm Title
Sham rTMS (arm C)
Arm Type
Sham Comparator
Arm Description
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…)
Intervention Type
Device
Intervention Name(s)
Systematic maintenance rTMS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
rTMS course in case of relapse
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham rTMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cost-utility ratio, according to collective perspective of rTMS use in TRD compared to conventional therapeutic approaches without active rTMS.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cost-utility ratio, according to collective perspective of rTMS use in TRD compared to conventional therapeutic approaches without active rTMS.
Description
Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D) health-related quality of life questionnaire The costs will be measured by the additional of the following costs: Drugs dispensing via Health insurance database SNIIRAM, hospitalizations, work stoppages and care consumption collected in a declarative patient questionnaire
Time Frame
24 months
Title
Budget impact analysis of spreading the most efficient strategy for using rTMS (systematic mTMS or rTMS course in case of relapse).
Description
Comparison of intervention costs on the study sample and projection of these costs over 5 years, from the health insurance and hospital perspectives
Time Frame
5 years
Title
Major depressive disorder history
Description
This outcome will be assessed by patient interview, with the following data (not exhaustive): date of initial symptoms, length of the current episode, family antecedents of mood disorders.
Time Frame
Baseline
Title
Level of depression treatment-resistance
Description
Maudsley Staging model score: a multidimensional tool to quantify treatment resistance in depression. It evaluates 5 dimensions: 1) length of the current depressive episode, 2) symptomatic intensity, 3) failure of the antidepressant drugs, 4) Increase treatment 5) use of Electro-convulsive therapy. The total score ranges from 3 to 15. 15 being the highest level of treatment resistance.
Time Frame
Baseline
Title
professional status
Description
patient's professional status (active, unemployed, retired...)
Time Frame
Baseline,12 months and 24 months
Title
marital status
Description
patient's marital status (married, widow, single...)
Time Frame
Baseline,12 months and 24 months
Title
Response rate
Description
Response is defined as follows: decrease of the MADRS score by at least 50% compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score >34 being severe depression.
Time Frame
12 months and 24 months
Title
Remission rate
Description
Remission is defined as follows: MADRS score ≤ 10 (see detailed description of MADRS in outcome 8)
Time Frame
12 months and 24 months
Title
Relapse-free survival
Description
Number of patients with no relapse. Relapse is defined as follows: MADRS ≥ 20 (see detailed description of MADRS in outcome 8)
Time Frame
12 months and 24 months
Title
MADRS score
Description
MADRS score (see detailed description of MADRS in outcome 8)
Time Frame
Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
Title
Beck Depression Inventory (BDI) score
Description
The BDI is 13-item multiple-choice self-report inventory, for measuring the severity of depression. The global score is an addition of each item's score and ranges from 0 (minimal depression) to 39 (severe depression).
Time Frame
Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
Title
Clinical Global Impression (CGI) score
Description
The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. Each scale is rated from 0 to 7. 0 being the best level and 7 the worst level.
Time Frame
Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
Title
Adverse events linked to the medical treatment for depression
Description
Number and types of adverse events linked to the medical treatment for depression
Time Frame
24 months
Title
Declarative drug compliance via the MARS (Medication Adherence Report Scale)
Description
MARS is the Medication Adherence Report Scale, including 10 questions, the global score ranges from 0 to 10, 0 corresponds to the worst drug compliance and 10 to an excellent drug compliance
Time Frame
baseline, 12 months and 24 months
Title
Declarative drug compliance via the CRS (Clinician Rating Scale)
Description
CRS is the Clinician Rating Scale , including 7 questions, the global score ranges from 1 to 7, 7 being the worst level of drug compliance.
Time Frame
baseline, 12 months and 24 months
Title
Treatment(s) switch(es)
Description
Number of treatment switches per patient
Time Frame
Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
Title
Treatment(s) dose increase
Description
Number of drug(s) dose(s) increases prescribed to the patient
Time Frame
Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
Title
Treatments combination(s)
Description
List of drugs (name) prescribed to the patient
Time Frame
Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
Title
Rate of suicide attempts and suicides
Description
number of suicide attempts and suicides per patient
Time Frame
12 months and 24 months
Title
Patient's quality of life
Description
Short-Form 36 (SF 36) questionnaire: instrument used to assess multidimensional health-related quality of life, which measures 8 health related parameters: physical function, social function, physical role, emotional role, mental health, energy, pain, general health perceptions
Time Frame
baseline,12 months and 24 months
Title
Response rate at the end of rTMS courses
Description
Response is defined as follows: decrease of the MADRS score by at least 50% compared to baseline score (see detailed description of MADRS in outcome 8)
Time Frame
1 month after each rTMS treatments
Title
Remission rate at the end of rTMS courses
Description
Remission is defined as follows: MADRS score ≤ 10 (see detailed description of MADRS in outcome 8)
Time Frame
1 month after each rTMS treatments
Title
Number of days between the successive rTMS courses
Description
Number of days between end of rTMS course X and beginning of course X+1, for each patient
Time Frame
24 months
Title
Total number of rTMS sessions
Description
total number of rTMS sessions per patient
Time Frame
24 months
Title
Time between relapses
Description
Number of days between relapses, per patient
Time Frame
24 months
Title
Compliance with rTMS
Description
number of missed sessions over the number of planned sessions, per patient
Time Frame
24 months
Title
Patient acceptability of the rTMS technique: Analog Visual Scale
Description
Analog Visual Scale of acceptability of the rTMS completed by the patient, ranging from 0 to 10. 0 being "not acceptable" and 10 being "totally acceptable"
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 MADRS >19 Episode duration: 12 weeks to 3 years. 2 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Bulteau, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
CHRU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
CH le Vinatier Lyon
City
Bron
Country
France
Facility Name
CHU de Caen
City
Caen
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
Clinique de Vontes
City
Esvre-sur-Indre
Country
France
Facility Name
EPSM de Lille
City
Lille
Country
France
Facility Name
CH Esquirol - Limoges
City
Limoges
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
EPS de Ville-Evrard
City
Neuilly-sur-Marne
Country
France
Facility Name
GH PItié Salpétrière
City
Paris
Country
France
Facility Name
GHU Psychiatrie Ste Anne
City
Paris
Country
France
Facility Name
CH Henri Laborit (Poitiers)
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Centre hospitalier Guillaume Regnier Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
CH du Rouvray - Rouen
City
Rouen
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Facility Name
CHU de Tours / CHRU de Tours
City
Tours
ZIP/Postal Code
37540
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32248820
Citation
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.
Results Reference
derived

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Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression

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