Actively Recruiting
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression
Led by University Hospital of North Norway · Updated on 2024-08-02
50
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
U
University Hospital of North Norway
Lead Sponsor
U
UiT The Arctic University of Norway
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital North Norway
Tromsø, Norway, 9038
Actively Recruiting
Research Team
P
Per M Aslaksen, PhD
CONTACT
M
Marte C Ørbo, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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