DepressionNCT05516095
The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS)
A study testing Transcranial magnet stimulation in people with Depression and Executive Dysfunction, run by University Hospital of North Norway at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Depression, Executive Dysfunction
- What is being tested?
- Transcranial magnet stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteNorway
- Study dates
- 4 Jun 2022to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS) A Randomised Double-blind Sham-controlled Trial
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.
Read more
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.
- Conditions
- Depression, Executive Dysfunction
- Being tested
- Transcranial magnet stimulation, Sham Transcranial magnet stimulation
- Keywords
- moderate depression, major depression
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnet stimulationDevice
Also called Theta burst 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 stimulationDevice
Also called Sham Theta burst stimulation
Similar in appearance and give the same sound as the active device, but deliver no magnetic pulse that reach the brain
| Study group | Role | What they receive |
|---|---|---|
| Active iTBS | Active comparator | iTBS will be delivered with 120% of resting motor threshold, triplet 50 Hz bursts repeated at 5 Hz; 2 seconds on and 8 s off, 600 pulses per session with a total duration of 3 min 9 s. Treatment will be provided for 10 days for two consecutive weeks (except Saturdays and Sundays). Each patient will start treatment at the same time between 9 am and 3 pm during the 10-day treatment period. Receives: Device: Transcranial magnet stimulation |
| Sham iTBS | Placebo comparator | The sham system has an identical look, weight and sound compared to the true coil, and delivers electrical stimulation that can be felt at the skin but without penetrating the skull and thus not inducing any treatment effect. The sham stimulation will be given with the same procedure as the active stimulation; 2 seconds on and 8 s off, 600 pulses per session with a total duration of 3 min 9 s. Receives: Device: Sham Transcranial magnet stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale.
Clinician rated depression inventory.
Measured: Up to 4 months.
Beck's Depression Inventory - II.
Patient reported depression inventory.
Measured: Up to 4 months.
Secondary outcomes (6)
Beck's Anxiety Inventory.
Patient reported anxiety inventory.
Measured: Up to 4 months.
Wisconsin Card Sorting Test.
Performance based measure of executive functions.
Measured: Up to 2 weeks.
Delis-Kaplan Executive Function System.
Performance based measure of executive functions.
Measured: Up to 2 weeks.
Brief-A
Questionnaire for self-reported executive functioning.
Measured: Up to 4 months.
Whodas 2.0
Self-reported disability assessment schedule.
Measured: Up to 4 months.
Pittsburgh Sleep Quality Index.
Self-reported measure of sleep quality.
Measured: Up to 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start4 Jun 2022
- Primary completion22 Jun 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- UiT The Arctic University of Norway
- Responsible party
- Sponsor
- Investigators
- Per M Aslaksen, PhD, Principal investigator, UiT The Arctic University of NorwayMarte C Ørbo, PhD, Principal investigator, UiT The Arctic University of NorwayOle Grønli, MD, PhD, Principal investigator, University Hospital North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516095
- Sponsor's protocol ID
- 228765
- Other IDs
- HNF1578-21
- Status last verified
- Jun 2022
- First submitted
- 14 Feb 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data for outcome measures in the study.
Publications
Orbo MC, Gronli OK, Brochs MS, Friborg O, Vangberg TR, Selaas R, Larsen C, Mittner M, Turi Z, Csifcsak G, Aslaksen PM. Intermittent Theta-Burst Stimulation and Depressive Symptoms in Major Depressive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2621262. doi: 10.1001/jamanetworkopen.2026.21262.
PubMed 42418203Orbo MC, Gronli OK, Larsen C, Vangberg TR, Friborg O, Turi Z, Mittner M, Csifcsak G, Aslaksen PM. The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial. Trials. 2023 Oct 2;24(1):627. doi: 10.1186/s13063-023-07674-6.
PubMed 37784199
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS) A Randomised Double-blind Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT05516095
- Acronym / sponsor ID
- 228765
- Conditions
- Depression, Executive Dysfunction
- Keywords
- moderate depression, major depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- UiT The Arctic University of Norway
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- 22 Jun 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Active iTBS | Active comparator | Device: Transcranial magnet stimulationiTBS will be delivered with 120% of resting motor threshold, triplet 50 Hz bursts repeated at 5 Hz; 2 seconds on and 8 s off, 600 pulses per session with a total duration of 3 min 9 s. Treatment will be provided for 10 days for two consecutive weeks (except Saturdays and Sundays). Each patient will start treatment at the same time between 9 am and 3 pm during the 10-day treatment period. |
| Sham iTBS | Placebo comparator | Device: Sham Transcranial magnet stimulationThe sham system has an identical look, weight and sound compared to the true coil, and delivers electrical stimulation that can be felt at the skin but without penetrating the skull and thus not inducing any treatment effect. The sham stimulation will be given with the same procedure as the active stimulation; 2 seconds on and 8 s off, 600 pulses per session with a total duration of 3 min 9 s. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnet stimulationAlso: Theta burst stimulationTheta 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. | Device | Active iTBS |
| Sham Transcranial magnet stimulationAlso: Sham Theta burst stimulationSimilar in appearance and give the same sound as the active device, but deliver no magnetic pulse that reach the brain | Device | Sham iTBS |
Primary outcome
Montgomery-Asberg Depression Rating Scale.
Time frame: Up to 4 months.
Clinician rated depression inventory.
Beck's Depression Inventory - II.
Time frame: Up to 4 months.
Patient reported depression inventory.
6 secondary outcomes
Beck's Anxiety Inventory.
Time frame: Up to 4 months.
Wisconsin Card Sorting Test.
Time frame: Up to 2 weeks.
Delis-Kaplan Executive Function System.
Time frame: Up to 2 weeks.
Brief-A
Time frame: Up to 4 months.
Whodas 2.0
Time frame: Up to 4 months.
Pittsburgh Sleep Quality Index.
Time frame: Up to 4 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 42418203Orbo MC, Gronli OK, Brochs MS, Friborg O, Vangberg TR, Selaas R, Larsen C, Mittner M, Turi Z, Csifcsak G, Aslaksen PM. Intermittent Theta-Burst Stimulation and Depressive Symptoms in Major Depressive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2621262. doi: 10.1001/jamanetworkopen.2026.21262.
- Derived from this study: PubMed 37784199Orbo MC, Gronli OK, Larsen C, Vangberg TR, Friborg O, Turi Z, Mittner M, Csifcsak G, Aslaksen PM. The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial. Trials. 2023 Oct 2;24(1):627. doi: 10.1186/s13063-023-07674-6.
- Individual participant dataSharing planned: Yes. Anonymized data for outcome measures in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per M Aslaksen, PhD principal investigator
UiT The Arctic University of Norway
Marte C Ørbo, PhD principal investigator
UiT The Arctic University of Norway
Ole Grønli, MD, PhD principal investigator
University Hospital North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnet stimulation in people with Depression and Executive Dysfunction, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale. (time frame: Up to 4 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516095, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.