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New treatment option for Depression
Official title Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
ClinicalTrials.gov ID: NCT05732311
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- current harmful use or dependence on alcohol, amphetamines, cocaine, benzodiazepines, anticonvulsants, or opiates
- acute suicidality
- pregnancy
- current participation in another study
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Regensburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Regensburg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.