Major depressive disorder Persistent depressive disorder Bipolar disorder with current depression F31 F32 F33
Conditions
Interventions
Group 1: Intermittent Theta Burst Stimulation (Active iTBS) of the left dorsolateral prefrontal cortex
Group 2: Sham intermittent Theta Burst Stimulation (Sham iTBS)
Sponsors
Klinik für Psychiatrie und Psychotherapie, LMU Klinikum
Eligibility
Sex/Gender
All
Age
16 Years to 26 Years
Inclusion criteria
Inclusion criteria: - Diagnosis of major depressive disorder, persistent depressive disorder, or bipolar disorder with current depression (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, [DSM-5] criteria; assessed with the Diagnostic Interview for Mental Disorders [DIPS]) - No antidepressant or antipsychotic medication during the last 12 months, , except for short-term (< 2 weeks) on-demand medication - Fluent in reading and speaking German - Capable and willing to provide informed consent, as determined by the study physician
Exclusion criteria
Exclusion criteria: - Positive screening for acute mania (defined by reaching the threshold “mild or greater” on at least one question from the Adult DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure [from here on referred to as “APA screener”] Mania domain) - Positive screening for acute psychosis (defined by reaching the threshold “slight or greater” on at least one question from the APA screener Psychosis domain) - Comorbid Obsessive-Compulsive Disorder (OCD), operationalized as meeting the threshold of “mild or greater” on at least one item from the Repetitive Thoughts and Behaviors domain of the APA screener, followed by clinical confirmation of OCD by an experienced clinician - Severe borderline typical psychopathology, defined as a very-high mean score on the self-reported Borderline Symptom List (BSL-23) of =2.671 - Primary substance use disorder except for nicotine and caffeine (DSM-5, assessed with the DIPS) - Acute risk for suicidality, assessed by the Columbia Suicide Severity Rating Scale (C-SSRS; patient agrees to item 4 and/or item 5) - History of brain surgery, significant and clinically relevant brain malformation or neoplasm, head injury, stroke, dementia or other neurodegenerative disorder - History of seizures - Previous brain stimulation treatment (rTMS, transcranial direct current stimulation, electroconvulsive therapy, vagus nerve stimulation, deep brain stimulation) - Cardiac pacemakers, intracranial implant, or metal in the cranium - Antiepileptic drugs and/or benzodiazepines corresponding to > 1mg lorazepam/day - Severe somatic comorbidity as judged by the study physician - Pregnancy (negative urine HCG test in women) - Any clinically relevant findings in a structural MRI safety check (evaluated by a neuroradiologist) - Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of raw Montgomery–Åsberg Depression Rating Scale (MADRS) scores at week 6 (post-treatment visit) between active iTBS and sham iTBS, controlling for baseline MADRS scores | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change of raw MADRS scores between active iTBS and sham iTBS from baseline to months 3 and 6 (follow-up visits) - Differences in response rates (defined as = 50% reduction in raw MADRS score from baseline) between active iTBS and sham iTBS at week 6 (post-treatment visit), and at months 3 and 6 (follow-up visits) - Differences in remission rates (defined as a raw MADRS score = 10) between active iTBS and sham iTBS at week 6 (post-treatment visit), and at months 3 and 6 (follow-up visits) - Change of the depression, anxiety, and stress subscales of the DASS-21 between active iTBS and sham iTBS from baseline to week 6 (post-treatment visit), and to months 3 and 6 (follow-up visits) - Change of raw DARS scores between active iTBS and sham iTBS from baseline to week 6 (post-treatment visit), and to months 3 and 6 (follow-up visits) - Change of raw WHO-DAS 2.0 scores between active iTBS and sham iTBS from baseline to week 6 (post-treatment visit), and to months 3 and 6 (follow-up visits) Safety endpoints - Difference in rates of reported adverse events (AEs) between active iTBS and sham iTBS at week 6 (post-treatment visit) - Change of vital signs (blood pressure and heart rate) and Body Mass Index (BMI) between active iTBS and sham iTBS from baseline to week 6 (post-treatment visit) - Difference in rates of reported instances of suicidality (patient agrees to item 4 and/or item 5 on the C-SSRS) between active iTBS and sham iTBS at week 6 (post-treatment visit) Tolerability endpoints - Between-group difference in rates of participants who discontinue the treatment - Between-group difference in rates of participants who discontinue the treatment due to an AE | — |
Countries
Germany
Contacts
Public ContactGerrit Burkhardt
Klinik für Psychiatrie und Psychotherapie, LMU Klinikum
Outcome results
None listed