NCT05516095Completed
The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS)
The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS) A Randomised Double-blind Sham-controlled Trial
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
The present study is a randomized placebo-controlled trial examining the effect of intermittent theta burst stimulation (iTBS) on unipolar depression. iTBS is a form of transcranial magnet stimulation. The anti-depressive effect of two weeks of once- a - day neuronavigated iTBS over the dorsolateral left prefrontal cortex (DLPFC) will be investigated in comparison to sham (placebo) iTBS. Previous studies have shown that iTBS is an effective treatment for reducing symptoms of depression, but it is still unclear why some patients have a strong response to iTBS, whereas others show less or no reduction to test possible factors that can explain the inter-individual response to iTBS. Measures of cognitive functions, structural and functional brain data measured by Magnetic Resonance imaging (MRi), quality of life, sleep quality, general health status, and genetic measures will be obtained to answer the goals of this study. The main hypotheses are: 1) Patients receiving iTBS will display significantly larger reductions in depressive symptoms measured by the Montgomery-Asberg Depression Rating Scale and Becks Depression Inventory II compared to patients receiving sham stimulation. 2) Reduction in depressive symptoms will be significantly associated with a concomitant improvement in executive functions measured by neuropsychological tests. 3) Stronger connectivity at baseline between the DLFPC and the anterior cingulate cortices will be associated with better response to iTBS. 4) Variability in genetic measures will be significantly associated with treatment response to iTBS. 5) Variability in white matter structural measures of the brain will be significantly associated with the anti-depressive response to iTBS. Participants will be recruited prospectively, and the study performed at a single university hospital. After written informed consent is obtained from eligible, volunteering patients, baseline measurements will be administrated, and the patient will be allocated to either sham or active iTBS once a day for 10 consecutive workdays. Four weeks after the last treatment day, the patients will be followed up by phone interviews.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 73 (actual)
- First submitted
- 14 Feb 2022
- Start date
- 4 Jun 2022
- Primary completion date
- 22 Jun 2025
- Lead sponsor
- University Hospital of North Norway
- Diseases
- Depression
- NCT number
- NCT05516095
What you commit to
- Study type: Interventional
- Participants enrolled: 73
- From 4 Jun 2022 to the primary completion date, 22 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Previously diagnosed developmental disorder.
Other illness
- Bipolar disorder.
- Borderline personality disorder.
- Current eating disorders.
- Obsessive- compulsive disorders.
- Post-traumatic stress disorder.
- Any medical history of seizure.
- Any current cardiac or systemic disease.
Other
- The current depressive episode is clearly triggered by grief or a recent major stressful life event.
- Psychotic symptoms the last 6 months.
- Alcohol or substance abuse/addiction in the last 6 months.
- Any neurological or neurosurgical pathologies.
- Metallic prosthetic material or foreign objects in the body (pacemakers, internal cardioverter defibrillator units, insulin pump, prosthetic eye equipment, etc.).
- Pregnancy or lactating.
Who the study is looking for
- 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.
Age in the registry: 22 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital North Norway Coordinator of this site? Confirm its status | Tromsø | Norway | Unknown status |
Related publications
- Intermittent Theta-Burst Stimulation and Depressive Symptoms in Major Depressive Disorder: A Randomized Clinical Trial.JAMA Netw Open · 2026 · PMID 42418203
This page is information, not medical advice. Discuss any trial with your doctor.