NCT05732311 Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
| NCT ID | NCT05732311 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Berthold Langguth, MD, Ph.D. |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-04-25 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-04-25 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Berthold Langguth, Prof.
PRINCIPAL INVESTIGATOR
University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
Frequently Asked Questions
Who can join the NCT05732311 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05732311 currently recruiting?
Yes, NCT05732311 is actively recruiting participants. Contact the research team at martin.schecklmann@medbo.de for enrollment information.
Where is the NCT05732311 trial being conducted?
This trial is being conducted at Regensburg, Germany.
Who is sponsoring the NCT05732311 clinical trial?
NCT05732311 is sponsored by Berthold Langguth, MD, Ph.D.. The principal investigator is Berthold Langguth, Prof. at University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum. The trial plans to enroll 60 participants.
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