rTMS/CBT as next step in antidepressant non-responders. A randomized comparison with current stepped care approaches to major depressive disorder

Recruiting

Conditions: depression
major depressive disorder
10027946

Registration Number: NL-OMON54536

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

moderate or severe depression (HDRS-17 >16), without psychotic features, with a
current episode of less than two year and failed response to 2 adequate
dose-duration trials with antidepressants

Exclusion Criteria

-lifetime diagnosis of bipolar disorder, schizophrenia or schizoaffective
disorder, current substance abuse disorder, organic brain syndrome
- the 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 ETC

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome of the study is severity of depressive symptoms after 8 weeks<br /><br>of treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Economic evaluation by means of a cost-effectiveness and cost-utility analysis.<br /><br>Response (50% reduction in HDRS-17 score) and remission (< 7 on HDRS-17) after<br /><br>8 weeks of treatment and 4, 6, 9 and 12 months follow-up.<br /><br>Side-effects during the rTMS treatment and the medication treatment will be<br /><br>screened on a weekly basis during treatment, as well as at the follow-up<br /><br>moments after 4, 6, 9 and 12 months.<br /><br>Qualitative interviews with a selection of participants to explore barriers and<br /><br>facilitators of rTMS.</p><br>