F32
Conditions
Interventions
Group 1: Application of open-label Placebos (two times per day) on top off standard therapy (study-arm: OLP)
Group 2: Control Group with treatment as usual (study-arm: TAU)
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Age
16 Years to 18 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression scores after 28 days by means of CDRS-R | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression scores after 28 days by means of BDI-II | — |
Countries
Germany
Contacts
Public ContactChristian Engelhardt
Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters,LVR-Klinikum Essen, Kliniken der Universität Duisburg-Essen
Outcome results
None listed