F32.1 F32.2 F32.3
Conditions
Interventions
Group 1: Depressession (Adolescents) verum
non-invasive tDCS stimulation over the scalp using head electrodes
Group 2: Depression (Adolescents) sham
control condition without stimulation but same elec
Sponsors
Kinder- und JugendpsychiatrieEvangelisches Klinikum Bethel gGmbH
Eligibility
Sex/Gender
All
Age
13 Years to 17 Years
Inclusion criteria
Inclusion criteria: Written informed consent (parents) Written informed assent (participants) Age: 13-17;11 years at randomization Clinical diagnosis of depressive episode (ICD 10: F32.1, 32.2, 32.3, BDI-II >15) Both gender IQ > 80
Exclusion criteria
Exclusion criteria: Suicidality (clinical assessment) Bipolar disorder Schizophrenia Epilepsy/ epileptic seizure(s) in the past Family history of epileptic seizures Pregnancy or lactation Non-German-speaking youth or caregiver Low compliance (clinical assessment) Diagnosis of pervasive developmental and neurological disorder Participation in another clinical trial during the whole study period Past or present neurological disease or head surgery Born before the 37th week of pregnancy Birth weight < 2500 g Acute dermatological disease of scalp Substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to assess whether tDCS (transcraniell direct current stimulation) reduces patient reported severity of depressive symptoms compared with sham stimulation. We expect that the primary outcome Beck's Depression Inventory Revision (BDI-II) score between T1 (baseline) and T3 (4th week after the start of stimulation) will decrease. | — |
Secondary
| Measure | Time frame |
|---|---|
| The second objective is to assess feasibility, acceptability and adherence towards tDCS. | — |
Countries
Germany
Contacts
Public ContactOliver Bergau
KJP Bielefeld
Outcome results
None listed