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

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

Comparison of intervention costs on the study sample and projection of these costs over 5 years, from the health insurance and hospital perspectives

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.

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.

patient's professional status (active, unemployed, retired...)

patient's marital status (married, widow, single...)

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 is defined as follows: MADRS score ≤ 10 (see detailed description of MADRS in outcome 8)

Number of patients with no relapse. Relapse is defined as follows: MADRS ≥ 20 (see detailed description of MADRS in outcome 8)

MADRS score (see detailed description of MADRS in outcome 8)

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).

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.

Number and types of adverse events linked to the medical treatment for depression

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

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.

Number of treatment switches per patient

Number of drug(s) dose(s) increases prescribed to the patient

List of drugs (name) prescribed to the patient

number of suicide attempts and suicides per patient

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 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 is defined as follows: MADRS score ≤ 10 (see detailed description of MADRS in outcome 8)

Number of days between end of rTMS course X and beginning of course X+1, for each patient

total number of rTMS sessions per patient

Number of days between relapses, per patient

number of missed sessions over the number of planned sessions, per patient

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"