Open-Label Placebo Application in Addition to Standard Therapy in order to increase therapeutic Benefits during Treatment of adolescents with Major Depressio
- Conditions
- F32Depressive episode
- Registration Number
- DRKS00019048
- Lead Sponsor
- niversitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Major depression; diagnosis according to DSM-5, ascertained by a board certified child and adolescent psychiatrist or psychotherapist by means of a semi-structured diagnostic interview (Kinder-DIPS-Open-Access; parent and child/adolescent version; Margraf et al., 2017)
Informed consent from parents and patient
Any of the following co-morbide (actual or life-time) mental disorders: eating disorder, schizophrenia, manic episode(s)
Actual somatic or neurologic disease incuding epilepsia
IQ < 85
Inability to comprehend or speak German
Current treatment with antidepressants
Known lactose intolerance
Known allergies against other components of the placebo pills (Lactose-monohydrate, cellulose powder, magnesiumstearat (Ph. Eur.), and microcrystalline cellulose)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depression scores after 28 days by means of CDRS-R
- Secondary Outcome Measures
Name Time Method Depression scores after 28 days by means of BDI-II