Se Clinical Study Protocol OMEGA-3 FATTY ACIDS AS FIRST-LINE TREATMENT IN PAEDIATRIC DEPRESSION. A phase III, 36-week, multi-centre, double-blind, placebo-controlled randomized superiority Study. The Omega-3-pMDD Study Study Type: Intervention with Investigational Medicinal Product (IMP) Study Categorisation: Clinical Trial with IMP Category C Study Registration: Swiss Federal Complementary Database Clinicaltrials.gov Study Identifier: SNF 33IC30_166826 Sponsor, Sponsor- Gregor Berger Investigator and Principal Investigator: Department of Child and Adolescent Psychiatry University Hospital of Psychiatry University of Zurich Neumünsterallee 9 Omega-3-pMDD, Version 3 of 13.07.2017 Page 1 of 108 CH 8032 Zürich Switzerland Phone: +41 43 499 26 71 Mobile: +41 76 464 61 54 E-Mail:
[email protected] Investigational Product: Omega-3 fatty acids (1000mg EPA / 500mg DHA in > in 13 years old and 500mg EPA / 250mg DHA in < in 13 years old) Protocol Version and Version3 of 13..07.2017 Date: CONFIDENTIAL The information contained in this document is confidential and the property of the Department of Child and Adolescent Psychiatry of the University of Zurich. The information may not - in full or in part - be transmitted, reproduced, published, or disclosed to others than the applicable Independent Ethics Committee(s) and Competent Authority(ies) without prior written authorization from the Department of Child and Adolescent Psychiatry of the University of Zurich, except to the extent necessary to obtain informed consent from those participants who will participate in the study. Omega-3-pMDD, Version 3 of 13.07.2017 Page 2 of 108 SIGNATURE PAGES Study number Swiss Federal Complementary Database Study Title Omega-3 fatty acids as first-line treatment in Paediatric Depression.