Using intermittent theta burst stimulation to maintain depression treatment
Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
NA · University of Regensburg · NCT05732311
This study is testing whether giving people with depression who have benefited from a specific brain stimulation treatment either once a week or all at once can help them stay feeling better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Regensburg (other) |
| Locations | 1 site (Regensburg) |
| Trial ID | NCT05732311 on ClinicalTrials.gov |
What this trial studies
This study involves a randomized, multi-center, open-label approach where patients with depression who previously responded to intermittent theta burst stimulation (iTBS) will receive this treatment as maintenance therapy. Participants will be divided into two groups based on the frequency of stimulation: one group will receive standard iTBS over a week, while the other will receive accelerated iTBS in one day. An interim analysis will be conducted after half of the patients have been treated to estimate the effect size.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of a depressive episode, recurrent depressive disorder, or bipolar disorder who have responded positively to prior iTBS treatment.
Not a fit: Patients with severe neurological diseases or those with contraindications for TMS, such as electrical implants, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel maintenance therapy option for patients with depression, potentially improving their long-term outcomes.
How similar studies have performed: While the use of iTBS has shown promise in treating depression, this specific approach as maintenance therapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Regensburg
- Department of Psychiatry and Psychotherapy, University of Regensburg — Regensburg, Germany (RECRUITING)
Study contacts
- Principal investigator: Berthold Langguth, Prof. — University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
- Study coordinator: Martin Schecklmann, Prof.
- Email: martin.schecklmann@medbo.de
- Phone: +49-941-941-2054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression