The Omega-3 Fatty Acid Paediatric Depression Trial (Omega-3-pMDD)
Depression
About this trial
This is an interventional treatment trial for Depression focused on measuring omega-3 fatty acids, eicosapentaenoic acid, docosahexaenoic acid, antidepressants, suicidality, cognition, childhood depression, pediatric depression
Eligibility Criteria
Inclusion Criteria:
- Male or female in- or outpatients of a participating centre
- Children aged 8 <13 years or teenager aged 13 to < 18 years
- Major depressive disorder with depressive symptoms of at least moderate severity
- Written informed consent of the parents / legal representatives and patients' assent
Exclusion Criteria:
- contraindications to the drug
- more than 4 weeks of regular omega-3 supplementation
- pregnant or breastfeeding or intention to become pregnant
- pre-existing neurological or medical conditions likely to be responsible for depressive symptoms
- laboratory screening values considered clinically relevant
- known or suspected non-compliance
- other psychiatric diagnoses (substance dependency, schizophrenia, bipolar affective disorder, eating disorder, mental retardation, pervasive developmental disorder)
- inability to follow the procedures of the study
- Participation in another study with omega-3, previous enrolment in the current study, or dependent persons of the investigators
Sites / Locations
- Psychiatric Services Baselland
- Klinik Sonnenhof
- Clienia Littenheid
- Spital Thurgau Kinder- und Jugendpsychiatrischer Dienst
- Psychiatric University Clinics, Department of Child and Adolescent Psychiatry
- University Psychiatric Services
- Stiftung Kinder- und Jugendpsychiatrische Dienste St.Gallen
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Omega-3 fatty acid oil
Placebo oil
A daily dose of 500mg EPA/ 250mg DHA in the 8 to <13 year olds, and 1000mg EPA / 500mg DHA in the 13 to <18 years olds, respectively, will be added to standardized treatment according to the German S3 Guidelines for the treatment of depression in children and adolescents
Placebo capsules will contain mostly medium chain triglycerides (MCT) and also a small amount of fish oil to mimic the fishy flavour and taste. Placebo will be added to standardized treatment according to the German S3 Guidelines for the treatment of depression in children and adolescents