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

Nantes University Hospital (NUH)

Status: Active, not recruiting

Conditions: Treatment-resistant Depression

Treatments: Device: Systematic maintenance rTMS; Device: sham rTMS; Device: rTMS course in case of relapse

Study type: Interventional

Funder types: Other

Identifiers

NCT03701724

RC17_0494

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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119 participants in 3 patient groups

Systematic maintenance rTMS (arm A)

Experimental group

Description:

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

Treatment:

Device: Systematic maintenance rTMS

rTMS course in case of relapse (arm B)

Experimental group

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...)

Treatment:

Device: rTMS course in case of relapse

Sham rTMS (arm C)

Sham Comparator group

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...)

Treatment:

Device: sham rTMS