Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBerthold Langguth, MD, Ph.D.
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- intermittend theta burst stimulation
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Berthold Langguth, MD, Ph.D.
Lead sponsor
University of Regensburg
Sponsor institution
Source ClinicalTrials.gov