Cost-effectiveness of rTMS/CBT as next step in antidepressant non-responders. A randomized comparison with current stepped care approaches to major depressive disorder
Projectomschrijving
In dit onderzoek zal de (kosten)-effectiviteit van repetitieve transcraniele magnetische stimulatie (rTMS) in vergelijking met antidepressiva onderzocht worden. In de huidig richtlijn voor depressie worden patiënten met een depressieve stoornis, naast cognitieve gedragstherapie (CGT), behandeld met achtereenvolgende medicamenteuze stappen. Echter, na 2 van dergelijke stappen is de kans dat medicatie aanslaat vrij klein, terwijl rTMS dan een aantrekkelijk alternatief biedt met waarschijnlijk meer effectiviteit. Het onderzoek zal plaats vinden in de vorm van een gerandomiseerd klinische trial, waarbij patiënten at random worden toegewezen aan medicatie of rTMS, beide in combinatie met CGT. Vervolgens wordt het effect van deze behandelingen nauwkeurig gevolgd gedurende een jaar. Het onderzoek start in januari 2019, in samenwerking met een aantal andere ziekenhuizen en GGz instellingen in de regio en loopt tot en met 2022.
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Samenvatting van de aanvraag
RESEARCH QUESTION(S) Is rTMS in combination with CBT a cost-effective treatment alternative for the current pharmacological switch in combination with CBT for depressed patients with a moderate level of treatment-resistance? HYPOTHESIS Compared to treatment as usual, rTMS in combination with CBT will result in a larger reduction of depressive symptoms STUDY DESIGN A randomized, multicenter, prospective clinical superiority trial with regular assessments during a 6 month follow up STUDY POPULATION(S) / DATASETS Patients with moderate to severe, non-psychotic, unipolar depression, who did not respond to 2 adequate antidepressant trials INTERVENTION 6 weeks of treatment with repetitive transcranial magnetic stimulation (rTMS) and cognitive behavior therapy (CBT) on top of continued antidepressants [rTMS + AD cont + CBT] USUAL CARE / COMPARISON Optimal treatment as usual according to the Dutch stepped care guideline, consisting of either switching or augmenting antidepressants in combination with CBT [AD switch + CBT] OUTCOME MEASURES Clinical outcome is determined by the reduction in depressive symptoms measured by the Hamilton depression rating scale (HDRS-17) after 6 weeks of treatment and at 2 and 6 months follow up. We will also calculate remission (HDRS-17 <7) and response (50% reduction HDRS-17) rates at these timepoints. Quality of life and societal costs and health consumption will be assessed for the economic evaluation during the six-month follow-up period. SAMPLE SIZE CALCULATION / DATA ANALYSIS To flag up a clinical meaningful effect size of d=0.33 (differential effect of rTMS over TAU) as statistically significant, requires 73 participants per condition for a 2-sided test at alpha=0.05 and with a power of (1-beta)=0.80. To compensate for loss-to-follow-up (estimated at 10%) we aim to recruit 162 patients. We will analyse the data based on intention to treat and employ a repeated measures ANCOVA. COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS An economic evaluation from a societal perspective and a budget impact analysis according to state of the art guidelines will be embedded in the trial. TIME SCHEDULE We intend to start in October 2018. The first three months we will finalize ethical approval and prepare for the study, including trial registration and attunement of the standard operating procedures (SOP) within and across centres. Note that we only include centres that are experienced in all three treatment modalities and rTMS in particular. Inclusion of patients at the different centres starts in January 2019 until the last follow-up assessments in March 2022, after which we have 6 months for final analysing and reporting the results to complete the study in September 2022.