Methylphenidate treatment of adult male prison inmates with attention-deficit hyperactivity disorder: randomised double-blind placebo-controlled trial with open-label extension

BackgroundAttention-deficit hyperactivity disorder (ADHD) is highly prevalent in prison inmates, but pharmacological treatment has not yet been evaluated in this group.AimsTo evaluate osmotic-release oral system (OROS) methylphenidate in adult male long-term prison inmates with ADHD.MethodRandomised, double-blind, placebo-controlled 5-week trial, followed by 47-week open-label extension in 30 prison inmates with ADHD and comorbid disorders. Primary outcome was level of ADHD symptoms after 5 weeks, evaluated by a masked assessor. Secondary outcomes were self-reported ADHD symptoms, global severity and global functioning throughout the 52-week trial, and post hoc treatment response and numbers needed to treat (NNT) (trial registration: NCT00482313.)ResultsTreatment significantly improved ADHD during the trial (P<0.001; Cohen's d = 2.17), with reduced symptom severity and improved global functioning. The placebo response, cardiovascular measures and adverse events were non-significant; the NNT was 1.1. Attention-deficit hyperactivity disorder symptoms, global severity and global functioning continued to improve during the open-label extension.ConclusionsOsmotic-release oral system methylphenidate is an effective treatment for adult male prison inmates with ADHD.

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Functional improvement and correlations with symptomatic improvement in adults with attention deficit hyperactivity disorder receiving long-acting methylphenidate

Psychological Medicine ◽

10.1017/s0033291711000845 ◽

2011 ◽

Vol 42 (1) ◽

pp. 195-204 ◽

Cited By ~ 15

Author(s):

J. K. Buitelaar ◽

M. Casas ◽

A. Philipsen ◽

J. J. S. Kooij ◽

J. A. Ramos-Quiroga ◽

...

Keyword(s):

Quality Of Life ◽

Attention Deficit Hyperactivity Disorder ◽

Attention Deficit ◽

Daily Functioning ◽

Open Label ◽

Double Blind ◽

Hyperactivity Disorder ◽

Co Morbidity ◽

Open Label Extension

BackgroundData on the relationship between core symptoms and daily functioning in adults with attention deficit hyperactivity disorder (ADHD) are limited. Daily functioning was assessed as part of an open-label extension, and associations with symptom scores were evaluated.MethodAfter a 5-week double-blind study with adults with ADHD receiving osmotic-controlled release oral delivery system (OROS) methylphenidate (MPH) 18, 36 or 72 mg/day, or placebo, participants were eligible for a 7-week open-label extension in which all patients received OROS MPH. Data for the Conners' Adult ADHD Rating Scale – Observer: Screening Version (CAARS-O:SV) (primary endpoint) have been presented previously. Secondary endpoints included the observer self-reported short version of the CAARS (CAARS-S:S) and the Clinical Global Impressions – Severity Scale (CGI-S). Daily functioning and quality of life were assessed using the Sheehan Disability Scale (SDS) and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) respectively. In post-hoc analyses, changes in CAARS-O:SV were evaluated in subgroups. Relationships between symptom and functional outcomes were evaluated in a multivariate regression analysis.ResultsA total of 370 patients entered the open-label extension. Significant improvements from baseline in CAARS-O:SV were similar regardless of sex, ADHD subtype, prior treatment or psychiatric co-morbidity. Significant improvements from double-blind baseline were also seen for the CAARS-S:S, CGI-S, SDS and Q-LES-Q. Improvements in the CAARS-O:SV Hyperactivity/Impulsivity subscale were associated with improvements in SDS total and subscale scores, and in the Q-LES-Q score at open-label endpoint. Improvements in CAARS-O:SV Inattention subscale and CGI-S scores were not significantly associated with functional changes.ConclusionsImprovements in ADHD symptoms relating to hyperactivity and impulsivity in adults receiving OROS MPH are associated with improvements in daily functioning and quality of life.

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The effect of phosphatidylserine containing Omega3 fatty-acids on attention-deficit hyperactivity disorder symptoms in children: A double-blind placebo-controlled trial, followed by an open-label extension

European Psychiatry ◽

10.1016/j.eurpsy.2011.05.004 ◽

2012 ◽

Vol 27 (5) ◽

pp. 335-342 ◽

Cited By ~ 42

Author(s):

I. Manor ◽

A. Magen ◽

D. Keidar ◽

S. Rosen ◽

H. Tasker ◽

...

Keyword(s):

Fatty Acids ◽

Attention Deficit Hyperactivity Disorder ◽

Adhd Symptoms ◽

Open Label ◽

Double Blind ◽

Double Blind Placebo ◽

Hyperactivity Disorder ◽

Adhd Children ◽

Open Label Extension ◽

To Receive

AbstractObjectiveTo study the efficacy and safety of phosphatidylserine (PS) containing Omega3 long-chain polyunsaturated fatty acids attached to its backbone (PS-Omega3) in reducing attention-deficit/ hyperactivity disorder (ADHD) symptoms in children.MethodA 15-week, double-blind, placebo-controlled phase followed by an open-label extension of additional 15 weeks. Two hundred ADHD children were randomized to receive either PS-Omega3 or placebo, out of them, 150 children continued into the extension. Efficacy was assessed using Conners’ parent and teacher rating scales (CRS-P,T), Strengths and Difficulties Questionnaire (SDQ), and Child Health Questionnaire (CHQ). Safety evaluation included adverse events monitoring.ResultsThe key finding of the double-blind phase was the significant reduction in the Global:Restless/impulsive subscale of CRS-P and the significant improvement in Parent impact-emotional (PE) subscale of the CHQ, both in the PS-Omega3 group. Exploratory subgroup analysis of children with a more pronounced hyperactive/impulsive behavior, as well as mood and behavior-dysregulation, revealed a significant reduction in the ADHD-Index and hyperactive components. Data from the open-label extension indicated sustained efficacy for children who continued to receive PS-Omega3. Children that switched to PS-Omega3 treatment from placebo showed a significant reduction in subscales scores of both CRS-P and the CRS-T, as compare to baseline scores. The treatment was well tolerated.ConclusionsThe results of this 30-week study suggest that PS-Omega3 may reduce ADHD symptoms in children. Preliminary analysis suggests that this treatment may be especially effective in a subgroup of hyperactive-impulsive, emotionally and behaviorally-dysregulated ADHD children.

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