This is a randomized, multi-center, open-label study in which patients with depression who responded to an open-label treatment with intermittent theta burst stimulation (iTBS) will receive this procedure as maintenance therapy. The patients will be randomized to two study arms. The arms differ in the frequency of stimulation (standard iTBS (5 treatments every working day for one week) vs. accelerated iTBS (5 treatments in one day)). For purposes of effect size estimation an interim analysis will be done after half of the patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* adult women and men aged 18 to 70 years with an ICD-10 diagnosis of a depressive episode of depressive disorder (F32), recurrent depressive disorder (F33), or bipolar disorder (F31)
* moderate or severe current episode prior to initial open iTBS treatment (HAMD-21 \>16 points)
* response to iTBS treatment (either reduction in HAMD score by 50% or score at the end of treatment \<11 points)
* no concomitant psychotic symptoms.
* no other relevant psychiatric disorder as assessed by the study physician
* residence in Germany and German speaking that allows understanding of the information provided
* patient is capable of giving consent
Exclusion Criteria:
* fulfillment of the general contraindications for TMS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps).
* severe neurological diseases (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, malformations of the brain, severe head injury in the history)
* current harmful use or dependence on alcohol, amphetamines, cocaine, benzodiazepines, anticonvulsants, or opiates
* acute suicidality
* pregnancy
* current participation in another study
Primary outcome measure(s)
relapse (number of patients who have a relapse for depression) — 33 weeks 50% increase of symptoms according to Hamilton depression rating scale
Trial sites (1)
Facility
City
Region
Status
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg
Germany
Recruiting
More Berthold Langguth, MD, Ph.D. trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.