NCT06534684Recruiting
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression A Randomised Double-blind Sham-controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The present project aims to assess the neurocognitive impact of a two-week once-a-day regimen of intermittent theta burst stimulation (iTBS) compared to sham iTBS, when targeting the left dorsolateral prefrontal cortex (LDLPFC) in clinically depressed outpatients. The study investigates the relationships between changes in cerebral measures and cognitive performance on an N-back task in relation to the antidepressive effect following iTBS.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 25 May 2024
- Start date
- 12 Feb 2024
- Primary completion date
- Jun 2025
- Lead sponsor
- University Hospital of North Norway
- Diseases
- Depression
- NCT number
- NCT06534684
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 12 Feb 2024 to the primary completion date, 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 episode fulfills the criteria for a major depressive episode requiring inpatient treatment and/or electroconvulsive therapy,
- Currently using of antipsychotic medication or benzodiazepines - or any medication that interferes with motor threshold excitability
Other illness
- Bipolar disorder
- Borderline personality disorder
- Current eating disorders
- Obsessive- compulsive disorders
- Post-traumatic stress disorder
- A life-time medical history of seizure
- Cardiac or systemic disease
Other
- The current depressive episode is in the mild range
- The current depressive episode is clearly triggered by grief or a recent major stressful life event
- Psychotic symptoms
- Alcohol or substance abuse/addiction in the last 6 months
- Neurological or neurosurgical pathologies
- Metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.)
- Autism
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 22 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital North Norway Coordinator of this site? Confirm its status | Tromsø | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.