OBJECTIVE: To assess ADHD symptoms after switching from Methylphenidate Immediate-release (MPH-IR) to Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS) in clinically stable patients with ADHD and to identify predictors of dissatisfaction with MPH-SODAS. METHODS: This is an 8-week open clinical trial. Patients were assigned to MPH-SODAS according to their pre-study dose of MPH-IR. Assessments at baseline were conducted using the Swanson, Nolan, and Pelham-IV Questionnaire (SNAP-IV), and the Barkley's Side Effect Rating Scale (SERS). Potentials predictors of treatment response were evaluated. RESULTS:From 62 patients, 47 completed the protocol. There was no significant change in the total score at the SNAP-IV (F (1,51.26) = 0.01; P = 0.91) and its subscales scores during the trial. Although no significant effect on the SERS total score (F (1,111.49) = 0.75; P = 0.39) was found, one adult patient with a previous cardiovascular condition presented a hemorrhagic cerebral vascular accident resulting in her obit. Overall, 46 (74.2%) patients reported to be satisfied. No factor assessed predicted dissatisfaction in univariated analyses. CONCLUSION: Results suggested that switching from MPH-IR to MPH-SODAS did not affect stabilization of ADHD symptoms in the majority of patients. MPH prescription in patients with previous cardiovascular conditions must be extremely careful. Further studies with long-acting MPH including larger samples and patients not responsive to MPH-IR are needed especially in countries outside the US.
RCT Entities:
OBJECTIVE: To assess ADHD symptoms after switching from Methylphenidate Immediate-release (MPH-IR) to MethylphenidateSpheroidal Oral Drug Absorption System (MPH-SODAS) in clinically stable patients with ADHD and to identify predictors of dissatisfaction with MPH-SODAS. METHODS: This is an 8-week open clinical trial. Patients were assigned to MPH-SODAS according to their pre-study dose of MPH-IR. Assessments at baseline were conducted using the Swanson, Nolan, and Pelham-IV Questionnaire (SNAP-IV), and the Barkley's Side Effect Rating Scale (SERS). Potentials predictors of treatment response were evaluated. RESULTS: From 62 patients, 47 completed the protocol. There was no significant change in the total score at the SNAP-IV (F (1,51.26) = 0.01; P = 0.91) and its subscales scores during the trial. Although no significant effect on the SERS total score (F (1,111.49) = 0.75; P = 0.39) was found, one adult patient with a previous cardiovascular condition presented a hemorrhagic cerebral vascular accident resulting in her obit. Overall, 46 (74.2%) patients reported to be satisfied. No factor assessed predicted dissatisfaction in univariated analyses. CONCLUSION: Results suggested that switching from MPH-IR to MPH-SODAS did not affect stabilization of ADHD symptoms in the majority of patients. MPH prescription in patients with previous cardiovascular conditions must be extremely careful. Further studies with long-acting MPH including larger samples and patients not responsive to MPH-IR are needed especially in countries outside the US.
Authors: Christopher J Kratochvil; Marybeth Lake; Steven R Pliszka; John T Walkup Journal: J Am Acad Child Adolesc Psychiatry Date: 2005-05 Impact factor: 8.829
Authors: J M Swanson; H C Kraemer; S P Hinshaw; L E Arnold; C K Conners; H B Abikoff; W Clevenger; M Davies; G R Elliott; L L Greenhill; L Hechtman; B Hoza; P S Jensen; J S March; J H Newcorn; E B Owens; W E Pelham; E Schiller; J B Severe; S Simpson; B Vitiello; K Wells; T Wigal; M Wu Journal: J Am Acad Child Adolesc Psychiatry Date: 2001-02 Impact factor: 8.829
Authors: Guilherme V Polanczyk; Mariana Eizirik; Victor Aranovich; Daniel Denardin; Tatiana L da Silva; Tatiana V da Conceição; Thiago G Pianca; Luis Augusto Rohde Journal: Braz J Psychiatry Date: 2003-06 Impact factor: 2.697
Authors: Elizabeth B Owens; Stephen P Hinshaw; Helen C Kraemer; L Eugene Arnold; Howard B Abikoff; Dennis P Cantwell; C Keith Conners; Glen Elliott; Laurence L Greenhill; Lily Hechtman; Betsy Hoza; Peter S Jensen; John S March; Jeffrey H Newcorn; William E Pelham; Joanne B Severe; James M Swanson; Benedetto Vitiello; Karen C Wells; Timothy Wigal Journal: J Consult Clin Psychol Date: 2003-06
Authors: Ole Jakob Storebø; Nadia Pedersen; Erica Ramstad; Maja Lærke Kielsholm; Signe Sofie Nielsen; Helle B Krogh; Carlos R Moreira-Maia; Frederik L Magnusson; Mathilde Holmskov; Trine Gerner; Maria Skoog; Susanne Rosendal; Camilla Groth; Donna Gillies; Kirsten Buch Rasmussen; Dorothy Gauci; Morris Zwi; Richard Kirubakaran; Sasja J Håkonsen; Lise Aagaard; Erik Simonsen; Christian Gluud Journal: Cochrane Database Syst Rev Date: 2018-05-09