Actively Recruiting

Phase Not Applicable
Age: 22Years - 65Years
All Genders
NCT06534684

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

Age: 22Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital North Norway

Tromsø, Norway, 9038

Actively Recruiting

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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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The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression | DecenTrialz