rTMS in combination with CBT is a more (cost)effective treatment option for patients with non-psychotic depression with a moderate level of treatment resistance compared to treatment as usual (switching to a tricyclic antidepressant (TCA) or…
ID
Source
Brief title
Condition
- Depressed mood disorders and disturbances
Health condition
Major depressive disorder
Research involving
Sponsors and support
Intervention
- Medical device
Outcome measures
Primary outcome
Score on the Hamilton Depression Rating Scale (HDRS-17)
Secondary outcome
Remission (cost-effectiveness) Quality adjusted life years
Background summary
Rationale: Repetitive transcranial magnetic stimulation (rTMS) is widely used both in fundamental cognitive neuroscientific studies as well as clinical applied studies investigating its potential mood stabilizing role. Objectives: To examine the effect of high frequency rTMS over the left DLPFC in combination with CBT as a cost-effective treatment alternative for the current pharmacological switch in combination with CBT for depressed patients with a moderate level of treatment-resistance. Study design: A randomized, multicenter, prospective clinical superiority trial with regular assessments during a 12 month follow up from baseline onwards. 90 patients with moderate to severe, non-psychotic, unipolar depression, who did not respond to 2 adequate antidepressant trials, will be included. The intervention consists of max. 25 sessions of repetitive transcranial magnetic stimulation (rTMS) over the course of 8 weeks (schema of 4, 4, 4, 3, 3, 3, 2, 2 sessions per week) and cognitive behavior therapy (CBT) on top of continued antidepressants (AD) [rTMS + AD cont + CBT]. The control condition consists of a switch in AD according to the Dutch stepped care guidelines and CBT. Main study parameters/endpoints: Clinical outcome is determined by the reduction in depressive symptoms measured by the Hamilton depression rating scale (HDRS-17) after 8 weeks of treatment and 4 and 6 months follow up. We will also calculate remission (HDRS-17 <7) and response (50% reduction HDRS-17) rates at these time points. Quality of life and societal costs and health consumption will be assessed for the economic evaluation during the six month follow-up period. An extended follow-up until twelve months will be available for a subgroup of patients.
Study objective
rTMS in combination with CBT is a more (cost)effective treatment option for patients with non-psychotic depression with a moderate level of treatment resistance compared to treatment as usual (switching to a tricyclic antidepressant (TCA) or augmenting TCA with an atypical antipsychotic or lithium, in combination with CBT).
Study design
Baseline, 8 weeks of treatment, follow-up at 4 and 6 months, extended follow-up at 9 and 12 months
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS) + cognitive behavioral therapy (CBT) Treatment as usual (switching to TCA or augmenting TCA with atypical antipsychotic or lithium) + cognitive behavioral therapy (CBT)
Age
Inclusion criteria
>18 years of age. Failed response to 2 adequate dose-duration trials with antidepressants. Current episode of less than two years. Moderate or severe depression (HDRS-17 > 16) without psychotic features.
Exclusion criteria
Lifetime diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder, current substance abuse disorder, or organic brain syndrome. Presence of a concurrent significant medical condition impeding the ability to participate. Previous treatment with rTMS. Epilepsy, convulsion or seizure. Serious head trauma or brain surgery. Large or ferromagnetic metal parts in the head (except for a dental wire) Implanted cardiac pacemaker or neurostimulator. Pregnancy. Previous treatment with ECT.
Design
Recruitment
IPD sharing statement
p/a Radboudumc, huispost 628,
Postbus 9101
6500 HB Nijmegen
024 361 3154
commissiemensgebondenonderzoek@radboudumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7628 |
| CCMO | NL68540.091.19 |
| OMON | NL-OMON54536 |