Assessing brain and cognitive changes after a new depression treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project evaluates the effects of intermittent theta burst stimulation (iTBS) on patients with moderate depression by targeting the left dorsolateral prefrontal cortex. It is a randomized, sham-controlled, double-blind clinical trial where participants receive either active or sham iTBS once daily for two weeks. The study aims to measure changes in brain function and cognitive performance through a series of assessments before, during, and after the treatment period. The relationship between these changes and the antidepressant effects of iTBS will be explored.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital North Norway
  Tromsø, Norway Recruiting

Study contacts

• Study coordinator: Per M Aslaksen, PhD
• Email: per.aslaksen@unn.no
• Phone: 77649234

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.