Status:
RECRUITING
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression
Lead Sponsor:
University Hospital of North Norway
Collaborating Sponsors:
UiT The Arctic University of Norway
Conditions:
Depression, Unipolar
Depression Moderate
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
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...
Detailed Description
The study is a randomized sham controlled double blind clinical trial in which the changes in cortical functions associated with the anti-depressive effect of two weeks of once-a-day neuronavigated iT...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 12 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06534684
Start Date
February 12 2024
End Date
February 12 2029
Last Update
August 2 2024
Active Locations (1)
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1
University Hospital North Norway
Tromsø, Norway, 9038