Non-invasive brain stimulation for treating depression without medication
Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant
This study is testing if a new non-drug treatment called intermittent theta burst stimulation can help people with depression who haven't used antidepressants feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Regensburg Academic / other |
| Locations | 1 site (Regensburg) |
| Trial ID | NCT05732298 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intermittent theta burst stimulation (iTBS) as a treatment for patients with depressive disorders who have not been treated with antidepressant medications. The study involves 72 participants who are randomly assigned to either receive immediate treatment or be placed on a wait-list for four weeks. The primary goal is to evaluate the impact of iTBS on depressive symptoms compared to a control group that undergoes 'watchful waiting'. An interim analysis will be conducted after 36 patients have been treated to assess early outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with unipolar or bipolar depression who have not received adequate antidepressant treatment.
Not a fit: Patients with active suicidality, significant neurological conditions, or those currently participating in other trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide an effective alternative for patients with depression who refuse or cannot tolerate traditional antidepressant medications.
How similar studies have performed: While the use of iTBS is a relatively novel approach, preliminary studies have shown promise in similar non-invasive brain stimulation techniques for treating depression.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * uni- or bipolar depression according to ICD-10 * present episode at least four weeks * 18-70 years old * no intake and rejection of anti-depressant medication and * no adequate anti-depressant medication in the present episode * no or stable non-drug anti-depressant treatment (e.g. psychotherapy) * residency in Germany, German speaking Exclusion Criteria: * contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker * relevant neurological or internistic diseases according to study investigator * participation in other trials during treatment * pregnancy or breatfeeding * legal care and placement in a psychiatric hospital * active suicidality
Where this trial is running
Regensburg
- Department of Psychiatry and Psychotherapy — 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.com
- Phone: +49-941-941-1256
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.