Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 238
- Locations
- 7
- Primary Endpoint
- Response rate of Montgomery-Asberg Depression Rating Scale (MADRS)
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
This is a randomized, double-blind, sham-controlled multicenter clinical trial. The aim is to provide evidence for efficacy of TBS in the treatment of patients with major depression. There will be a direct comparison between combined cTBS/iTBS with sham TBS. Overall, 236 patients with major depression will be randomized either to active TBS or sham TBS in a 1:1 ratio. The planned stimulation paradigms will be applied as add-on therapy to standard therapy (antidepressive medication and / or psychotherapy). Patients will receive 30 stimulation sessions in a 6-week treatment period (one session daily from Monday to Friday). Follow up assessments are scheduled 1 and 3 months after end of treatment period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •moderate or severe unipolar depression diagnosed according to criteria of Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)
- •duration of the current episode must be ≥ 6 weeks and ≤ 2 years
- •HDRS17 ≥ 18
- •mild to moderate treatment resistance according to the Antidepressant Treatment History Form \[ATHF-SF\]. Treatment resistance is defined as having failed at least one but no more than three adequate antidepressant treatments in this episode
- •stable antidepressive medication 4 weeks before treatment or no antidepressive treatment
- •no further relevant psychiatric axis-I and/or axis-II disorder except for anxiety disorders (according to DSM-5 and SCID-5-PD)
- •no comorbid psychotic symptoms
- •ability to give consent
Exclusion Criteria
- •acute suicidality (MADRS item 10 score \> 4)
- •antiepileptic drugs and/or benzodiazepines corresponding to \> 1mg lorazepam / day
- •history of brain surgery, significant and clinically relevant brain malformation or neoplasm, head injury, stroke, dementia or other neurodegenerative disorder
- •history of seizures
- •previous rTMS treatment
- •lifetime history of non-response to adequate electroconvulsive therapy (minimum of eight treatments)
- •deep brain stimulation
- •cardiac pacemakers, intracranial implant, or metal in the cranium
- •substance dependence or abuse in the past 3 months (with the exception of tobacco)
- •severe somatic comorbidity as judged by the study physician
Outcomes
Primary Outcomes
Response rate of Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 6 weeks
MADRS reduction of at least 50% of baseline value after end of treatment period between active combined iTBS / cTBS and the sham condition. (rater questionnaire; MADRS raw score ranges between 0 and 60; the higher the score, the more severe depression)
Secondary Outcomes
- Reduction of raw score: Clinical Global Impression (CGI)(6 weeks)
- Reduction of raw score: Beck Depression Inventory (BDI-II)(10 and 18 weeks)
- Examination of the influence of Childhood Trauma Questionnaire (CTQ) at baseline as possible predictor for change of MADRS(6 weeks)
- Deterioration rate after treatment period(6 weeks)
- Work Productivity and Activity Impairment Questionnaire (WPAI)(6 and 18 weeks)
- Reduction of raw score: Hamilton Depression Rating Scale 17 items (HDRS17)(6 weeks)
- Frequency of adverse events(6 weeks)
- Examination of the influence of cognitive performance at baseline as possible predictor for change of MADRS(6 weeks)
- Remission rate after treatment(6 weeks)
- Reduction of raw score: Montgomery-Asberg Depression Rating Scale (MADRS)(6 weeks)
- Reduction of raw score: WHO-5 well-being index(10 and 18 weeks)