Using rTMS to treat mood and cognitive symptoms of depression
Multisite Repetitive Transcranial Magnetic Stimulation for Mood, Cognitive Impairment, Anhedonia and Disordered Sleep in Depressive Disorder
This study is testing if a new way of using brain stimulation can help improve mood and thinking problems in people with unipolar and bipolar depression who haven't found relief from regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Jagiellonian University Academic / other |
| Locations | 1 site (Krakow) |
| Trial ID | NCT06363981 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on mood, cognitive impairment, anhedonia, and sleep disorders in patients with unipolar depression and bipolar disorder. It aims to compare the therapeutic potential of multi-site stimulation over the left dorsolateral prefrontal cortex (DLPFC) and dorsomedial prefrontal cortex (dmPFC) against stimulation over the DLPFC alone and a sham treatment. The study includes patients with moderate to severe depressive episodes and assesses their symptoms using standardized scales. By exploring this novel approach, the study seeks to optimize rTMS as a treatment option for those who are resistant to conventional pharmacotherapy.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing moderate to severe depressive episodes without psychotic symptoms.
Not a fit: Patients with psychotic symptoms, recent suicidal ideations, or contraindications to rTMS will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from depression and related cognitive impairments.
How similar studies have performed: While some studies have explored rTMS for depression, this multi-site approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion * Hamilton Depression Rating Scale between between 20 and 35 points at inclusion * The score in the Athens Insomnia Scale eight or more * The score of three or more points in items 4 and 21 of the Beck Depressions Inventory 2 * Complaining about problems with memory and concentration timely related with the onset of depression Exclusion Criteria: * Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy * Psychotic symptoms at the time of inclusion * Suicidal ideations and/or attempts within three months prior to inclusion
Where this trial is running
Krakow
- The Education of Research and Development Center, Babinski Clinical Hospital — Krakow, Poland (Recruiting)
Study contacts
- Principal investigator: Wojciech Korzeniowski, MD — The Education of Research and Development Center, Babinski Clinical Hospital
- Study coordinator: Wojciech Korzeniowski, MD
- Email: wojciech.korzen@gmail.com
- Phone: +48 12 652 45 20
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.