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NCT Number: NCT05516095

The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS)

The present study is a randomized placebo-controlled trial examining the effect of intermittent theta burst stimulation (iTBS) on unipolar depression. iTBS is a form of transcranial magnet stimulation.

The anti-depressive effect of two weeks of once- a - day neuronavigated iTBS over the dorsolateral left prefrontal cortex (DLPFC) will be investigated in comparison to sham (placebo) iTBS. Previous studies have shown that iTBS is an effective treatment for reducing symptoms of depression, but it is still unclear why some patients have a strong response to iTBS, whereas others show less or no reduction to test possible factors that can explain the inter-individual response to iTBS.

Measures of cognitive functions, structural and functional brain data measured by Magnetic Resonance imaging (MRi), quality of life, sleep quality, general health status, and genetic measures will be obtained to answer the goals of this study.

The main hypotheses are: 1) Patients receiving iTBS will display significantly larger reductions in depressive symptoms measured by the Montgomery-Asberg Depression Rating Scale and Becks Depression Inventory II compared to patients receiving sham stimulation. 2) Reduction in depressive symptoms will be significantly associated with a concomitant improvement in executive functions measured by neuropsychological tests. 3) Stronger connectivity at baseline between the DLFPC and the anterior cingulate cortices will be associated with better response to iTBS. 4) Variability in genetic measures will be significantly associated with treatment response to iTBS. 5) Variability in white matter structural measures of the brain will be significantly associated with the anti-depressive response to iTBS.

Participants will be recruited prospectively, and the study performed at a single university hospital. After written informed consent is obtained from eligible, volunteering patients, baseline measurements will be administrated, and the patient will be allocated to either sham or active iTBS once a day for 10 consecutive workdays. Four weeks after the last treatment day, the patients will be followed up by phone interviews.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Executive Dysfunction Mental Disorders Mood Disorders

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital North Norway

Tromsø, 9038, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A MADRS score of =/ > 20 (moderate depression).
  • 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 and is to be kept stable throughout the study until 4 weeks after the last day of iTBS treatment.
  • 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 or contrary that 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 the last 6 months.
  • Alcohol or substance abuse/addiction in the last 6 months.
  • Current eating disorders.
  • Obsessive- compulsive disorders.
  • Post-traumatic stress disorder.
  • Any medical history of seizure.
  • Any neurological or neurosurgical pathologies.
  • Any current cardiac or systemic disease.
  • Metallic prosthetic material or foreign objects in the body (pacemakers, internal cardioverter defibrillator units, insulin pump, prosthetic eye equipment, etc.).
  • Previously diagnosed developmental disorder.
  • Pregnancy or lactating.

Treatment and study plan

Transcranial magnet stimulation

Device

Theta burst stimulation, which is a form of Transcranial magnet stimulation, works by inducing focused magnetic field pulses to make durable changes in the activity of brain regions. The magnetic pulses are transferred to the brain through an electromagnetic coil.

Other names: Theta burst stimulation

Sham Transcranial magnet stimulation

Device

Similar in appearance and give the same sound as the active device, but deliver no magnetic pulse that reach the brain

Other names: Sham Theta burst stimulation

Primary outcomes

  1. Montgomery-Asberg Depression Rating Scale.

    Time frame: Up to 4 months.

    Clinician rated depression inventory.

  2. Beck's Depression Inventory - II.

    Time frame: Up to 4 months.

    Patient reported depression inventory.

Secondary outcomes

  1. Beck's Anxiety Inventory.

    Time frame: Up to 4 months.

    Patient reported anxiety inventory.

  2. Wisconsin Card Sorting Test.

    Time frame: Up to 2 weeks.

    Performance based measure of executive functions.

  3. Delis-Kaplan Executive Function System.

    Time frame: Up to 2 weeks.

    Performance based measure of executive functions.

  4. Brief-A

    Time frame: Up to 4 months.

    Questionnaire for self-reported executive functioning.

  5. Whodas 2.0

    Time frame: Up to 4 months.

    Self-reported disability assessment schedule.

  6. Pittsburgh Sleep Quality Index.

    Time frame: Up to 4 months.

    Self-reported measure of sleep quality.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • UiT The Arctic University of Norway

Registry information

Official study title

The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS) A Randomised Double-blind Sham-controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 25, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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