Transcranial direct current stimulation in the treatment of juvenile depression in a naturalistic inpatient setting: A double-blind randomized controlled feasibility trial
- Conditions
- Severe depressive episode without psychotic symptomsF32.2F32.1F32.3Moderate depressive episodeSevere depressive episode with psychotic symptoms
- Registration Number
- DRKS00027066
- Lead Sponsor
- Kinder- und JugendpsychiatrieEvangelisches Klinikum Bethel gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The second objective is to assess feasibility, acceptability and adherence towards tDCS.