Assessing brain and cognitive changes after a new depression treatment
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression A Randomised Double-blind Sham-controlled Trial
This study is testing whether a new brain stimulation treatment can improve mood and thinking skills in people with moderate depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital of North Norway Academic / other |
| Locations | 1 site (Tromsø) |
| Trial ID | NCT06534684 on ClinicalTrials.gov |
What this trial studies
This project evaluates the effects of intermittent theta burst stimulation (iTBS) on patients with moderate depression by targeting the left dorsolateral prefrontal cortex. It is a randomized, sham-controlled, double-blind clinical trial where participants receive either active or sham iTBS once daily for two weeks. The study aims to measure changes in brain function and cognitive performance through a series of assessments before, during, and after the treatment period. The relationship between these changes and the antidepressant effects of iTBS will be explored.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with moderate depression who have had a stable drug therapy for at least three weeks.
Not a fit: Patients with mild depression, major depressive episodes requiring hospitalization, or those with certain psychiatric disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel, non-invasive option for patients suffering from moderate depression.
How similar studies have performed: Other studies have shown promise with similar non-invasive brain stimulation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Patients must meet the diagnostic criteria of at least a moderate depression * The duration of the current depressive episode must have lasted more than 2 weeks but less than 2 years * Drug therapy must have been stable for the last three weeks prior to the first treatment day with iTBS * Patients must volunteer to provide informed consent, be able to follow the treatment schedule and have a satisfactory safety screening for iTBS and MRI Exclusion criteria: * The current depressive episode is in the mild range * The current episode fulfills the criteria for a major depressive episode requiring inpatient treatment and/or electroconvulsive therapy, * The current depressive episode is clearly triggered by grief or a recent major stressful life event * Bipolar disorder * Borderline personality disorder * Psychotic symptoms * Alcohol or substance abuse/addiction in the last 6 months * Current eating disorders * Obsessive- compulsive disorders * Post-traumatic stress disorder * A life-time medical history of seizure * Neurological or neurosurgical pathologies * Cardiac or systemic disease * Metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.) * Autism * Pregnancy * Currently using of antipsychotic medication or benzodiazepines - or any medication that interferes with motor threshold excitability
Where this trial is running
Tromsø
- University Hospital North Norway — Tromsø, Norway (Recruiting)
Study contacts
- Study coordinator: Per M Aslaksen, PhD
- Email: per.aslaksen@unn.no
- Phone: 77649234
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.