Depression Bipolar, Depression - Major Depressive Disorder
Conditions
Keywords
rtms, itbs, repetitive transcranial magnetic stimulation, randomized controlled trial, intermittent theta-burst stimulation
Brief summary
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: * Observer rated response according to Clinical Global Impression Scale-Improvement (≥2 point reduction CGI). * Response to treatment (a decrease of 50% on MADRS-S) * Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS). * Drop-out from treatment. * Stimulation site pain measured with the Numerical Rating Scales (NRS). * Adverse events. * Admission and suicides within 6 months. * New treatment course of rTMS or ECT within 6 months * Remission (score \< 11 on the MADRS-S) * Memory impairment measured with the Comprehensive Psychopathological Rating Scale (CPRS). Study population: Patients with unipolar or bipolar depression. Sample size: 350 patients. Inclusion criteria: * At least 18 years of age at the time of inclusion. * A clinical diagnosis of unipolar or bipolar depression according to ICD-10. * Acceptance of rTMS. * A Swedish personal identity number. * Capable of giving informed consent. 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
Interventions
DEVICErepetitive transcranial magnetic stimulation
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.
DEVICEintermittent theta burst stimulation
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)
Sponsors
Uppsala County Council, Sweden
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age at the time of inclusion. * A clinical diagnosis of unipolar or bipolar depression according to ICD-10. * Acceptance of rTMS. * A Swedish personal identity number. * Capable of giving informed consent.
Exclusion criteria
• If the investigator judges one of the two treatment protocols inappropriate for the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction in the MADRS-S score | 6 weeks | reduction in the MADRS-S score from baseline to the end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGI-I | 6 weeks | Professionally determined response according to Clinical Global Impression Scale-Improvement (CGI-I) |
| Patient rate remission | 6 weeks | Remission (score \< 11 on the MADRS-S) |
| Patient rated response | 6 weeks | Response to treatment (a decrease of 50% on MADRS-S) |
| Self-rated EQ-5D-VAS | 6 weeks | Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS) |
| Stimulation site pain | 15 minutes | Stimulation site pain (self-rated by patients using Numerical Rating Scales (NRS)). |
| Adverse events | 6 weeks, follow-up at 6 months | Adverse events including severe adverse events |
| Self-rated EQ-5D-VAS at 6-month follow-up | 6 months | Self-rated global health measured with the EQ-5D-VAS at 6-month follow-up |
| Self rated remission at 6-month follow-up | 6 months | Self rated remission (score \< 11 on MADRS-S) at 6-month follow-up |
| Hospital admission | 6 months | Hospital admissions for depression, hypomanic/manic switch, suicide attempts, and deaths including completed suicides within 6 months after randomization |
| Drop-out | 6 weeks | Drop-out from treatment for any reason within 30 sessions |
Countries
Sweden
Contacts
Primary ContactAxel Nordenskjöld, MD,PhD
Backup ContactCecilia Vestlund, MD
Outcome results
None listed