- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03701724
Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression (ACOUSTIM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Angers, France, 49100
- CHU d'Angers
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Besançon, France, 25000
- CHRU De Besancon
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Bron, France
- CH le Vinatier Lyon
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Caen, France
- CHU de Caen
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Clermont-Ferrand, France
- CHU de Clermont-Ferrand
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Dijon, France
- CHU de Dijon
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Esvre-sur-Indre, France
- Clinique de Vontes
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Lille, France
- EPSM de Lille
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Limoges, France
- CH Esquirol - Limoges
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Montpellier, France
- CHU de Montpellier
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Nantes, France, 44000
- Nantes University Hospital
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Neuilly-sur-Marne, France
- EPS de Ville-Evrard
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Paris, France
- GH Pitié Salpêtrière
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Paris, France
- GHU Psychiatrie Ste Anne
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Poitiers, France, 86000
- CH Henri Laborit (Poitiers)
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Rennes, France, 35000
- Centre hospitalier Guillaume Regnier Rennes
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Rouen, France
- CH du Rouvray - Rouen
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Toulouse, France
- CHU de Toulouse
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Tours, France, 37540
- CHU de Tours / CHRU de Tours
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Systematic maintenance rTMS (arm A)
Active rTMS treatment followed, for responders, by systematic maintenance rTMS Depression usual medical treatment (psychosocial approach and/or pharmacotherapy and/or, ECT…)
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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.
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Experimental: rTMS course in case of relapse (arm B)
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…)
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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.
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Sham Comparator: Sham rTMS (arm C)
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…)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-utility ratio, according to collective perspective of rTMS use in TRD compared to conventional therapeutic approaches without active rTMS.
Time Frame: 12 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-utility ratio, according to collective perspective of rTMS use in TRD compared to conventional therapeutic approaches without active rTMS.
Time Frame: 24 months
|
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 |
24 months
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Budget impact analysis of spreading the most efficient strategy for using rTMS (systematic mTMS or rTMS course in case of relapse).
Time Frame: 5 years
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Comparison of intervention costs on the study sample and projection of these costs over 5 years, from the health insurance and hospital perspectives
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5 years
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Major depressive disorder history
Time Frame: Baseline
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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.
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Baseline
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Level of depression treatment-resistance
Time Frame: Baseline
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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.
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Baseline
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professional status
Time Frame: Baseline,12 months and 24 months
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patient's professional status (active, unemployed, retired...)
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Baseline,12 months and 24 months
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marital status
Time Frame: Baseline,12 months and 24 months
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patient's marital status (married, widow, single...)
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Baseline,12 months and 24 months
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Response rate
Time Frame: 12 months and 24 months
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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.
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12 months and 24 months
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Remission rate
Time Frame: 12 months and 24 months
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Remission is defined as follows: MADRS score ≤ 10 (see detailed description of MADRS in outcome 8)
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12 months and 24 months
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Relapse-free survival
Time Frame: 12 months and 24 months
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Number of patients with no relapse.
Relapse is defined as follows: MADRS ≥ 20 (see detailed description of MADRS in outcome 8)
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12 months and 24 months
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MADRS score
Time Frame: Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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MADRS score (see detailed description of MADRS in outcome 8)
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Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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Beck Depression Inventory (BDI) score
Time Frame: Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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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).
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Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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Clinical Global Impression (CGI) score
Time Frame: Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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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.
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Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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Adverse events linked to the medical treatment for depression
Time Frame: 24 months
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Number and types of adverse events linked to the medical treatment for depression
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24 months
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Declarative drug compliance via the MARS (Medication Adherence Report Scale)
Time Frame: baseline, 12 months and 24 months
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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
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baseline, 12 months and 24 months
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Declarative drug compliance via the CRS (Clinician Rating Scale)
Time Frame: baseline, 12 months and 24 months
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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.
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baseline, 12 months and 24 months
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Treatment(s) switch(es)
Time Frame: Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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Number of treatment switches per patient
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Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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Treatment(s) dose increase
Time Frame: Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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Number of drug(s) dose(s) increases prescribed to the patient
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Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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Treatments combination(s)
Time Frame: Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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List of drugs (name) prescribed to the patient
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Baseline, 2 months, 6 months , 9 months, 12 months, 18 months, 24 months
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Rate of suicide attempts and suicides
Time Frame: 12 months and 24 months
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number of suicide attempts and suicides per patient
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12 months and 24 months
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Patient's quality of life
Time Frame: baseline,12 months and 24 months
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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
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baseline,12 months and 24 months
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Response rate at the end of rTMS courses
Time Frame: 1 month after each rTMS treatments
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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)
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1 month after each rTMS treatments
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Remission rate at the end of rTMS courses
Time Frame: 1 month after each rTMS treatments
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Remission is defined as follows: MADRS score ≤ 10 (see detailed description of MADRS in outcome 8)
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1 month after each rTMS treatments
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Number of days between the successive rTMS courses
Time Frame: 24 months
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Number of days between end of rTMS course X and beginning of course X+1, for each patient
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24 months
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Total number of rTMS sessions
Time Frame: 24 months
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total number of rTMS sessions per patient
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24 months
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Time between relapses
Time Frame: 24 months
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Number of days between relapses, per patient
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24 months
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Compliance with rTMS
Time Frame: 24 months
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number of missed sessions over the number of planned sessions, per patient
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24 months
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Patient acceptability of the rTMS technique: Analog Visual Scale
Time Frame: 24 months
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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"
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24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samuel Bulteau, MD, Nantes University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC17_0494
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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