Intermittent theta burst stimulation for treating depression
The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS) A Randomised Double-blind Sham-controlled Trial
This study is testing whether a new brain stimulation treatment can help people with unipolar depression feel better over two weeks compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital of North Norway Academic / other |
| Locations | 1 site (Tromsø) |
| Trial ID | NCT05516095 on ClinicalTrials.gov |
What this trial studies
This randomized placebo-controlled trial investigates the effects of intermittent theta burst stimulation (iTBS) on patients with unipolar depression. Participants will receive daily iTBS treatments over two weeks, targeting the dorsolateral left prefrontal cortex, while a control group will receive sham stimulation. The study aims to explore the anti-depressive effects of iTBS and identify factors influencing individual responses to the treatment through various assessments, including cognitive functions and brain imaging. The research seeks to enhance understanding of iTBS as a potential therapeutic option for depression.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate unipolar depression lasting between two weeks and two years.
Not a fit: Patients with mild depression or those requiring inpatient treatment for major depressive episodes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from moderate to severe depression.
How similar studies have performed: Previous studies have indicated that iTBS can effectively reduce symptoms of depression, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A MADRS score of =/ \> 20 (moderate depression). * 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 and is to be kept stable throughout the study until 4 weeks after the last day of iTBS treatment. * 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 or contrary that 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 the last 6 months. * Alcohol or substance abuse/addiction in the last 6 months. * Current eating disorders. * Obsessive- compulsive disorders. * Post-traumatic stress disorder. * Any medical history of seizure. * Any neurological or neurosurgical pathologies. * Any current cardiac or systemic disease. * Metallic prosthetic material or foreign objects in the body (pacemakers, internal cardioverter defibrillator units, insulin pump, prosthetic eye equipment, etc.). * Previously diagnosed developmental disorder. * Pregnancy or lactating.
Where this trial is running
Tromsø
- University Hospital North Norway — Tromsø, Norway (Recruiting)
Study contacts
- Principal investigator: Per M Aslaksen, PhD — UiT The Arctic University of Norway
- Study coordinator: Per M Aslaksen, PhD
- Email: per.aslaksen@uit.no
- Phone: 4777649234
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.