Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
- Conditions
- Depression
- Interventions
- Device: intermittend theta burst stimulation
- Registration Number
- NCT05732311
- Lead Sponsor
- Berthold Langguth, MD, Ph.D.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description active treatment 2 intermittend theta burst stimulation 600 pulses of iTBS per day with 120% resting motor threshold applied five sessions in one day (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks) active treatment intermittend theta burst stimulation 600 pulses of iTBS per day with 120% resting motor threshold applied five days in one week; tapering interval over 8 months (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks)
- Primary Outcome Measures
Name Time Method relapse (number of patients who have a relapse for depression) 33 weeks 50% increase of symptoms according to Hamilton depression rating scale
- Secondary Outcome Measures
Name Time Method Major Depression Inventory 49 weeks Major Depression Inventory (range: 0-50; higher values = worse outcome)
Columbia-Suicide Severity Rating Scale 49 weeks Columbia-Suicide Severity Rating Scale (range: 0-6; higher values = worse outcome)
Beck Anxiety Index 49 weeks Beck Anxiety Index (range: 0-63; higher values = worse outcome)
Hamilton Depression Rating Scale 49 weeks Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)
World Health Organisation quality of life bref 49 weeks World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)
clinical global impression 49 weeks clinical global impression (range: 0-7; higher values = worse outcome)
Global Assessment of Functioning 49 weeks Global Assessment of Functioning (range: 0-100; lower values = worse outcome)
Trial Locations
- Locations (1)
Department of Psychiatry and Psychotherapy, University of Regensburg
🇩🇪Regensburg, Germany