Clinical trial NCT05732311: Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
Official title: Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: relapse (number of patients who have a relapse for depression)
timeFrame: 33 weeks
Secondary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: 49 weeks
measure: Major Depression Inventory
timeFrame: 49 weeks
measure: World Health Organisation quality of life bref
timeFrame: 49 weeks
measure: clinical global impression
timeFrame: 49 weeks
measure: Columbia-Suicide Severity Rating Scale
timeFrame: 49 weeks
measure: Beck Anxiety Index
timeFrame: 49 weeks
measure: Global Assessment of Functioning
timeFrame: 49 weeks
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Regensburg
Study officials:
affiliation: University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
name: Berthold Langguth, Prof.
role: PRINCIPAL_INVESTIGATOR
References: