PMID- 37291464
OWN - NLM
STAT- Publisher
LR  - 20231212
IS  - 1435-165X (Electronic)
IS  - 1018-8827 (Print)
IS  - 1018-8827 (Linking)
DP  - 2023 Jun 8
TI  - Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT 
      and open label extension.
LID - 10.1007/s00787-023-02236-2 [doi]
AB  - BACKGROUND: The Micronutrients for Attention-Deficit/Hyperactivity Disorder in 
      Youth (MADDY) study evaluated the efficacy and safety of a multinutrient formula 
      for children with ADHD and emotional dysregulation. The post-RCT open-label 
      extension (OLE) compared the effect of treatment duration (8 weeks vs 16 weeks) 
      on ADHD symptoms, height velocity, and adverse events (AEs). METHODS: Children 
      aged 6-12 years randomized to multinutrients vs. placebo for 8 weeks (RCT), 
      received an 8-week OLE for a total of 16 weeks. Assessments included the Clinical 
      Global Impression-Improvement (CGI-I), Child and Adolescent Symptom Inventory-5 
      (CASI-5), Pediatric Adverse Events Rating Scale (PAERS), and anthropometric 
      measures (height and weight). RESULTS: Of the 126 in the RCT, 103 (81%) continued 
      in the OLE. For those initially assigned to placebo, CGI-I responders increased 
      from 23% in the RCT to 64% in the OLE; those who took multinutrients for 16 weeks 
      increased from 53% (RCT) to 66% responders (OLE). Both groups improved on the 
      CASI-5 composite score and subscales from week 8 to week 16 (all p-values < 
      0.01). The group taking 16 weeks of multinutrients had marginally greater height 
      growth (2.3 cm) than those with 8 weeks (1.8 cm) (p = 0.07). No difference in AEs 
      between groups was found. CONCLUSION: The response rate to multinutrients by 
      blinded clinician ratings at 8 weeks was maintained to 16 weeks; the response 
      rate in the group initially assigned to placebo improved significantly with 8 
      weeks of multinutrients and almost caught up with 16 weeks. Longer time on 
      multinutrients did not result in greater AEs, confirming an acceptable safety 
      profile.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.
FAU - Leung, Brenda M Y
AU  - Leung BMY
AUID- ORCID: 0000-0002-4699-8086
AD  - Faculty of Health Sciences, University of Lethbridge, 4401 University Drive, 
      Lethbridge, AB, Canada. brenda.leung@uleth.ca.
FAU - Srikanth, Priya
AU  - Srikanth P
AUID- ORCID: 0000-0002-0906-6757
AD  - Oregon Health & Science University-Portland State University School of Public 
      Health, Portland, OR, USA.
FAU - Robinette, Lisa
AU  - Robinette L
AUID- ORCID: 0000-0002-9314-9538
AD  - Department of Human Sciences, The Ohio State University, Columbus, OH, USA.
FAU - Bruton, Alisha M
AU  - Bruton AM
AUID- ORCID: 0000-0002-5929-3149
AD  - Department of Psychiatry, Oregon Health & Science University, Portland, OR, USA.
FAU - Tost, Gabriella
AU  - Tost G
AUID- ORCID: 0000-0003-1464-4918
AD  - Department of Psychiatry, Oregon Health & Science University, Portland, OR, USA.
FAU - Hatsu, Irene
AU  - Hatsu I
AUID- ORCID: 0000-0003-0501-9088
AD  - Department of Human Sciences, The Ohio State University, Columbus, OH, USA.
FAU - Arnold, L Eugene
AU  - Arnold LE
AUID- ORCID: 0000-0002-0886-0692
AD  - Department of Psychiatry & Behavioral Health, The Ohio State University, 
      Columbus, OH, USA.
FAU - Johnstone, Jeanette M
AU  - Johnstone JM
AUID- ORCID: 0000-0003-3947-5540
AD  - Department of Psychiatry, Oregon Health & Science University, Portland, OR, USA.
AD  - Helfgott Research Institute, National University of Natural Medicine, Portland, 
      OR, USA.
LA  - eng
GR  - UL1TR002369; UL1TR002733/TR/NCATS NIH HHS/United States
GR  - UL1 TR000128/TR/NCATS NIH HHS/United States
GR  - UL1 TR002369/TR/NCATS NIH HHS/United States
GR  - K23 AT012068/AT/NCCIH NIH HHS/United States
GR  - UL1 TR002733/TR/NCATS NIH HHS/United States
GR  - R90AT008924; T32 AT002688; K23 AT012068-01/AT/NCCIH NIH HHS/United States
GR  - UL1TR000128/TR/NCATS NIH HHS/United States
GR  - T32 #AT002688/AT/NCCIH NIH HHS/United States
GR  - T32 AT002688/AT/NCCIH NIH HHS/United States
GR  - R90 AT008924/AT/NCCIH NIH HHS/United States
PT  - Journal Article
DEP - 20230608
PL  - Germany
TA  - Eur Child Adolesc Psychiatry
JT  - European child & adolescent psychiatry
JID - 9212296
SB  - IM
PMC - PMC10703999
MID - NIHMS1914427
OTO - NOTNLM
OT  - ADHD
OT  - Children
OT  - Multinutrients
OT  - Open-label
OT  - RCT
COIS- Dr. Arnold has received research funding from Forest, Lilly, Noven, Shire, 
      Supernus, Roche, and YoungLiving (as well as NIH and Autism Speaks); has 
      consulted with Pfizer, Tris Pharma, and Waypoint; and been on advisory boards for 
      Arbor, Ironshore, Otsuka, Pfizer, Roche, Seaside Therapeutics, Shire. The other 
      authors declare that they have no competing interests.
EDAT- 2023/06/09 01:09
MHDA- 2023/06/09 01:09
PMCR- 2024/12/08
CRDT- 2023/06/08 23:34
PHST- 2022/11/11 00:00 [received]
PHST- 2023/05/16 00:00 [accepted]
PHST- 2024/12/08 00:00 [pmc-release]
PHST- 2023/06/09 01:09 [medline]
PHST- 2023/06/09 01:09 [pubmed]
PHST- 2023/06/08 23:34 [entrez]
AID - 10.1007/s00787-023-02236-2 [pii]
AID - 10.1007/s00787-023-02236-2 [doi]
PST - aheadofprint
SO  - Eur Child Adolesc Psychiatry. 2023 Jun 8:10.1007/s00787-023-02236-2. doi: 
      10.1007/s00787-023-02236-2.