Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

Study Overview
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Brief Summary
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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.

Official Title
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Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

Conditions
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Depression

Intervention / Treatment
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* Device: intermittend theta burst stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active treatment<br>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) | Device: intermittend theta burst stimulation<br>* intermittend theta burst stimulation<br>|
| Active Comparator: active treatment 2<br>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) | Device: intermittend theta burst stimulation<br>* intermittend theta burst stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse (number of patients who have a relapse for depression) | 50% increase of symptoms according to Hamilton depression rating scale | 33 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale | Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome) | 49 weeks | 
| Major Depression Inventory | Major Depression Inventory (range: 0-50; higher values = worse outcome) | 49 weeks | 
| World Health Organisation quality of life bref | World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome) | 49 weeks | 
| clinical global impression | clinical global impression (range: 0-7; higher values = worse outcome) | 49 weeks | 
| Columbia-Suicide Severity Rating Scale | Columbia-Suicide Severity Rating Scale (range: 0-6; higher values = worse outcome) | 49 weeks | 
| Beck Anxiety Index | Beck Anxiety Index (range: 0-63; higher values = worse outcome) | 49 weeks | 
| Global Assessment of Functioning | Global Assessment of Functioning (range: 0-100; lower values = worse outcome) | 49 weeks |