Depression
Conditions
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.
Interventions
DEVICEintermittend theta burst stimulation
intermittend theta burst stimulation
Sponsors
Berthold Langguth, MD, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| relapse (number of patients who have a relapse for depression) | 33 weeks | 50% increase of symptoms according to Hamilton depression rating scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Depression Inventory | 49 weeks | Major Depression Inventory (range: 0-50; 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) |
| Hamilton Depression Rating Scale | 49 weeks | Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome) |
| Beck Anxiety Index | 49 weeks | Beck Anxiety Index (range: 0-63; higher values = worse outcome) |
| Global Assessment of Functioning | 49 weeks | Global Assessment of Functioning (range: 0-100; lower values = worse outcome) |
| Columbia-Suicide Severity Rating Scale | 49 weeks | Columbia-Suicide Severity Rating Scale (range: 0-6; higher values = worse outcome) |
Countries
Germany
Contacts
Primary ContactMartin Schecklmann, Prof.
Backup ContactMohamed Abdelnaim, Dr.
Outcome results
None listed