Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intermittend theta burst stimulation.
- Who it may be relevant to
- Registry conditions: Depression. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device intermittend theta burst stimulation
intermittend theta burst stimulation
Primary outcome measures
- relapse (number of patients who have a relapse for depression) [Time frame: 33 weeks]
Secondary outcome measures (7)
- Hamilton Depression Rating Scale [Time frame: 49 weeks]
- Major Depression Inventory [Time frame: 49 weeks]
- World Health Organisation quality of life bref [Time frame: 49 weeks]
- clinical global impression [Time frame: 49 weeks]
- Columbia-Suicide Severity Rating Scale [Time frame: 49 weeks]
- Beck Anxiety Index [Time frame: 49 weeks]
- Global Assessment of Functioning [Time frame: 49 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Department of Psychiatry and Psychotherapy, University of Regensburg — Regensburg
Identifiers
NCT: NCT05732311 · 22-3167-101