rTMS/CBT compared to antidepressant treatment

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24799

Enrollment

Registered

2019-03-29

Start date

2019-08-15

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) + cognitive behavioral therapy (CBT) Treatment as usual (switching to TCA or augmenting TCA with atypical antipsychotic or lithium) + cognitive beha

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Score on the Hamilton Depression Rating Scale (HDRS-17)	—

Secondary

Measure	Time frame
Remission (cost-effectiveness) Quality adjusted life years	—

Contacts

Public ContactIris Dalhuisen

Radboudumc Nijmegen

iris.dalhuisen@radboudumc.nl06-50098382

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)