Early intervention with repetitive theta burst stimulation in adolescents and young adults with depressive disorders: a sequential Bayesian, randomized controlled pilot trial

Phase 2

Recruiting

• Conditions: F33; Major depressive disorderPersistent depressive disorderBipolar disorder with current depression; F31; F32; Bipolar affective disorder; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00033313
• Lead Sponsor: Klinik für Psychiatrie und Psychotherapie, LMU Klinikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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 (has to be confirmed by an independent physician)

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)
- Positive screening for Obsessive-Compulsive Disorder (defined by reaching the threshold mild or greater” on at least one question from the APA screener Repetitive Thoughts and Behaviors domain)
- 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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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