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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-ID 23-06-043272 | Other Identifier | Swedish Medical Product Agency |
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| Name | Class |
|---|---|
| Uppsala County Council, Sweden | OTHER_GOV |
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Aim: The purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 Hz stimulation compared to left-sided intermittent theta burst stimulation (iTBS) in unipolar and bipolar depression.
Design: A national, non-inferiority, register-based, randomized trial, unmasked, with two treatment arms.
Primary objective: The primary objective is to determine if right-sided inhibitory 1-Hz stimulation to dorsolateral prefrontal cortex (DLPFC) is non inferior to iTBS in treating unipolar and bipolar depression by measuring reduction in Montgomery-Åsberg Depression Rating Scale, self-assessed version (MADRS-S) from baseline to end of treatment.
Secondary objectives: Include testing for differences in:
Study population: Patients with unipolar or bipolar depression. Sample size: 350 patients.
Inclusion criteria:
Exclusion criteria:
• If the investigator judges one of the two treatment protocols inappropriate for the patient.
Inclusion time: 2025-07-01 to 2029-01-01
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| right-sided rTMS | Experimental | right-sided inhibitory 1 Hz repetitive transcranial magnetic stimulation |
|
| left-sided iTBS | Active Comparator | left-sided intermittent theta burst stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive transcranial magnetic stimulation | Device | Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique that uses pulsed magnetic fields to activate or suppress specific brain regions. It is used to treat various conditions, including major depressive disorder, by inducing small electrical currents that stimulate nerve cells. |
| Measure | Description | Time Frame |
|---|---|---|
| reduction in the MADRS-S score | reduction in the MADRS-S score from baseline to the end of treatment | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulation site pain | Stimulation site pain (self-rated by patients using Numerical Rating Scales (NRS)). | 15 minutes |
| CGI-I | Professionally determined response according to Clinical Global Impression Scale-Improvement (CGI-I) |
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Inclusion Criteria:
Exclusion Criteria:
• If the investigator judges one of the two treatment protocols inappropriate for the patient.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Axel Nordenskjöld, MD,PhD | Contact | +46196021000 | axel.nordenskjold@regionorebrolan.se | |
| Cecilia Vestlund, MD | Contact | +46196021000 | cecilia.vestlund@regionorebrolan.se |
| Name | Affiliation | Role |
|---|---|---|
| Axel Nordenskjöld, MD, PhD | Region Örebro County, Örebro University | Study Chair |
| Robert Bodén, MD, PhD | Uppsala University, Region Uppsala County | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit for Brainstimulation | Recruiting | Örebro | Sweden | |||
| Unit for Brainstimulation |
Data will be available from the corresponding author upon reasonabe request
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|
| intermittent theta burst stimulation | Device | Intermittent theta-burst stimulation (iTBS) is a form of transcranial magnetic stimulation (TMS) used to modulate brain activity. It involves delivering brief bursts of magnetic pulses to specific brain regions, typically the left dorsolateral prefrontal cortex (DLPFC) |
|
| 6 weeks |
| Patient rate remission | Remission (score < 11 on the MADRS-S) | 6 weeks |
| Patient rated response | Response to treatment (a decrease of 50% on MADRS-S) | 6 weeks |
| Self-rated EQ-5D-VAS | Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS) | 6 weeks |
| Drop-out | Drop-out from treatment for any reason within 30 sessions | 6 weeks |
| Adverse events | Adverse events including severe adverse events | 6 weeks, follow-up at 6 months |
| Self-rated EQ-5D-VAS at 6-month follow-up | Self-rated global health measured with the EQ-5D-VAS at 6-month follow-up | 6 months |
| Self rated remission at 6-month follow-up | Self rated remission (score < 11 on MADRS-S) at 6-month follow-up | 6 months |
| Hospital admission | Hospital admissions for depression, hypomanic/manic switch, suicide attempts, and deaths including completed suicides within 6 months after randomization | 6 months |
| Recruiting |
| Uppsala |
| Sweden |
|
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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