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Does OROS-methylphenidate improve core symptoms and deficits in executive function? Results of an open-label trial in adults with attention deficit hyperactivity disorder.
Curr Med Res Opin 2006; 22(12):2557-66CM

Abstract

OBJECTIVE

This pilot, uncontrolled, open-label study evaluated the safety/tolerability and potential effectiveness of OROS-methylphenidate (OROS-MPH) in adult attention deficit hyperactivity disorder (ADHD).

METHODS

Adults with DSM-IV-defined ADHD were enrolled in this 38-day study. Retrospective childhood diagnosis was made using the Wender Utah Rating Scale. Eligible patients required a baseline Conners Adult ADHD Rating Scale (CAARS) score > or = 24, Clinical Global Impression of Severity (CGI-S) score > or = 4 (at least moderate illness), and Montgomery-Asberg Depression Rating Scale (MADRS) score < or = 16. Safety/tolerability measurements included adverse event reporting, vital signs, electrocardiograms (ECGs), weight, physical examination. Primary effectiveness evaluated changes in CAARS scores. Secondary effectiveness parameters included executive function.

RESULTS

Thirty-two patients formed the safety analysis; however, 30 comprised the effectiveness analysis since two patients did not meet diagnostic inclusion criteria. No serious adverse events were reported and there were no early withdrawals due to adverse events. There were no clinically significant changes in endpoint ECGs, physical examination, or blood pressure. Mean pulse rate increased by 5.9 beats/min (p = 0.003) and mean body weight decreased by 2.2 kg at endpoint (p < 0.0001). Total CAARS scores decreased significantly at endpoint as well as the inattention (p < 0.0001) and hyperactivity/impulsivity symptom subscales (p < 0.0001) separately. Statistically significant improvements were observed in executive function and all other secondary measures, including the CAARS self report, CGI-S/CGI-I, Subject Satisfaction with treatment and the Sheehan Disability Scale (SDS). Mean dose of OROS-MPH = 52.3 +/- 14.0 mg. Modal dose = 54 mg. Study limitations include: the lack of placebo control in the study design leading to potential observer bias, the exclusion of adults with unstable psychiatric and other medical conditions which is less reflective of clinical practice, and the short study duration.

CONCLUSIONS

This uncontrolled, open-label trial suggests that OROS-MPH is well tolerated, providing core symptom control with the added benefit of improving executive function. However, future larger, randomized, controlled trials are required.

Authors+Show Affiliations

Clinique Woodward, Sherbrooke, Quebec, Canada. cliniquewoodward@videotron.caNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17166338

Citation

Fallu, Angelo, et al. "Does OROS-methylphenidate Improve Core Symptoms and Deficits in Executive Function? Results of an Open-label Trial in Adults With Attention Deficit Hyperactivity Disorder." Current Medical Research and Opinion, vol. 22, no. 12, 2006, pp. 2557-66.
Fallu A, Richard C, Prinzo R, et al. Does OROS-methylphenidate improve core symptoms and deficits in executive function? Results of an open-label trial in adults with attention deficit hyperactivity disorder. Curr Med Res Opin. 2006;22(12):2557-66.
Fallu, A., Richard, C., Prinzo, R., & Binder, C. (2006). Does OROS-methylphenidate improve core symptoms and deficits in executive function? Results of an open-label trial in adults with attention deficit hyperactivity disorder. Current Medical Research and Opinion, 22(12), pp. 2557-66.
Fallu A, et al. Does OROS-methylphenidate Improve Core Symptoms and Deficits in Executive Function? Results of an Open-label Trial in Adults With Attention Deficit Hyperactivity Disorder. Curr Med Res Opin. 2006;22(12):2557-66. PubMed PMID: 17166338.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Does OROS-methylphenidate improve core symptoms and deficits in executive function? Results of an open-label trial in adults with attention deficit hyperactivity disorder. AU - Fallu,Angelo, AU - Richard,Caroline, AU - Prinzo,Rosanna, AU - Binder,Carin, PY - 2006/12/15/pubmed PY - 2007/1/12/medline PY - 2006/12/15/entrez SP - 2557 EP - 66 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 22 IS - 12 N2 - OBJECTIVE: This pilot, uncontrolled, open-label study evaluated the safety/tolerability and potential effectiveness of OROS-methylphenidate (OROS-MPH) in adult attention deficit hyperactivity disorder (ADHD). METHODS: Adults with DSM-IV-defined ADHD were enrolled in this 38-day study. Retrospective childhood diagnosis was made using the Wender Utah Rating Scale. Eligible patients required a baseline Conners Adult ADHD Rating Scale (CAARS) score > or = 24, Clinical Global Impression of Severity (CGI-S) score > or = 4 (at least moderate illness), and Montgomery-Asberg Depression Rating Scale (MADRS) score < or = 16. Safety/tolerability measurements included adverse event reporting, vital signs, electrocardiograms (ECGs), weight, physical examination. Primary effectiveness evaluated changes in CAARS scores. Secondary effectiveness parameters included executive function. RESULTS: Thirty-two patients formed the safety analysis; however, 30 comprised the effectiveness analysis since two patients did not meet diagnostic inclusion criteria. No serious adverse events were reported and there were no early withdrawals due to adverse events. There were no clinically significant changes in endpoint ECGs, physical examination, or blood pressure. Mean pulse rate increased by 5.9 beats/min (p = 0.003) and mean body weight decreased by 2.2 kg at endpoint (p < 0.0001). Total CAARS scores decreased significantly at endpoint as well as the inattention (p < 0.0001) and hyperactivity/impulsivity symptom subscales (p < 0.0001) separately. Statistically significant improvements were observed in executive function and all other secondary measures, including the CAARS self report, CGI-S/CGI-I, Subject Satisfaction with treatment and the Sheehan Disability Scale (SDS). Mean dose of OROS-MPH = 52.3 +/- 14.0 mg. Modal dose = 54 mg. Study limitations include: the lack of placebo control in the study design leading to potential observer bias, the exclusion of adults with unstable psychiatric and other medical conditions which is less reflective of clinical practice, and the short study duration. CONCLUSIONS: This uncontrolled, open-label trial suggests that OROS-MPH is well tolerated, providing core symptom control with the added benefit of improving executive function. However, future larger, randomized, controlled trials are required. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/17166338/Does_OROS_methylphenidate_improve_core_symptoms_and_deficits_in_executive_function_Results_of_an_open_label_trial_in_adults_with_attention_deficit_hyperactivity_disorder_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079906X154132 DB - PRIME DP - Unbound Medicine ER -