The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS)

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516095
• Other study ID #: 228765
• Secondary ID: HNF1578-21
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2022
• Source: University Hospital of North Norway
• Contact: Per M Aslaksen, PhD
• Phone: 4777649234
• Email: per.aslaksen[@]uit.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 31, 2027
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Executive Dysfunction

Intervention

Device:
• Transcranial magnet stimulation
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.
• Sham Transcranial magnet stimulation
Similar in appearance and give the same sound as the active device, but deliver no magnetic pulse that reach the brain

Locations

Country	Name	City	State
Norway	University Hospital North Norway	Tromsø

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	UiT The Arctic University of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale.	Clinician rated depression inventory.	Up to 4 months.
Primary	Beck's Depression Inventory - II.	Patient reported depression inventory.	Up to 4 months.
Secondary	Beck's Anxiety Inventory.	Patient reported anxiety inventory.	Up to 4 months.
Secondary	Wisconsin Card Sorting Test.	Performance based measure of executive functions.	Up to 2 weeks.
Secondary	Delis-Kaplan Executive Function System.	Performance based measure of executive functions.	Up to 2 weeks.
Secondary	Brief-A	Questionnaire for self-reported executive functioning.	Up to 4 months.
Secondary	Whodas 2.0	Self-reported disability assessment schedule.	Up to 4 months.
Secondary	Pittsburgh Sleep Quality Index.	Self-reported measure of sleep quality.	Up to 4 months.