RecruitingNot ApplicableNCT05732311

Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

Sponsor

Berthold Langguth, MD, Ph.D.

Enrollment

60 participants

Start Date

Apr 25, 2023

Study Type

INTERVENTIONAL

Conditions

Depression

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

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 Criteria6

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