Depressive Episode, Major Depressive Disorder
Conditions
Brief summary
The investigators compare the primary and secondary outcome measures using accelerated intermittent theta burst stimulation (aiTBS, 20 sessions active and 20 sessions sham in a counterbalanced crossover design) to treat depressive symptoms with 2 parallel arms of intervention: personalized (stimulation position based on participants' brain networks) vs conventional (stimulation in F3 position of the 10-20 EEG cap) aiTBS.
Interventions
DEVICENeuronavigated aiTBS
Accelerated intermittent theta burst stimulation (aiTBS, 4 sessions per day with at least 20 minutes pause between sessions) in the left dorsolateral prefrontal cortex (DLPFC)
Sponsors
University Medical Center Goettingen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The investigators compare study outcomes using aiTBS in personalized stimulation targets vs conventional F3 stimulation targets in parallel arms, each arm controlled by its respective sham stimulation in a counterbalanced crossover design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Men and women between the ages of 18 and 60 years * Diagnosis of major depressive disorder according to DSM 5 (F32.x according to ICD-10) or bipolar disorder (bipolar I or bipolar II) according to DSM 5 (F31.x according to ICD-10) and an acute depressive condition at the time of the initial examination in outpatient or inpatient treatment (e.g. Department of Psychiatry and Psychotherapy, UMG) * Availability of informed consent to participate in the study, including the examinations and interventions
Exclusion criteria
* Neurological diseases, current or previous * Other Axis I diagnoses that mimic the affective disorder, current or previous * Physical illnesses that could be related to the affective symptoms (so-called organic causes) * Illicit drug use in the past month * Substance dependence, current or previous * Physical illnesses which, depending on their type and severity, could interfere with the planned examinations, influence the parameters to be examined or endanger the test participant during the course of the examination * Medical contraindications against performing an MRT examination / rTMS application (such as metal parts in the body, e.g. implants, pacemakers, infusion pumps, metal splinters, etc.) * Pregnancy * Previously known cerebral-morphological abnormalities (e.g. tumor, lesion, etc.) * Evidence or history of epilepsy * Head trauma with a history of loss of consciousness * Unwillingness to be informed of incidental findings * Participation in an rTMS / EKT application within the last 8 weeks * Lack of the ability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale) | 6 weeks | Administer Rating Scale |
| heart rate and its variability in RR slope and RMSSD values | 4-6 weeks | Potential marker of treatment response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Rating Scale for Depression (HAMD-17 scores in units of scale) | 6 weeks | Administer Rating Scale |
| Beck Depression Inventory (BDI-2 scores in units of scale) | 6 weeks | Self Rating Scale |
| DMN decoupling / other networks in rho and z values | 4-6 weeks | Potential markers of treatment response |
| epi / genetic markers of neuroplasticity in ng | 5-6 weeks | Potential markers of treatment response |
Countries
Germany
Outcome results
None listed