Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults

Cândido, Raissa Carolina Fonseca; Pádua, Cristiane Aparecida Menezes de; Golder, Su; Junqueira, Daniela R

doi:10.1002/14651858.cd013011.pub2

Cited by 19 publications

(18 citation statements)

References 113 publications

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“…Data from multiple RCTs show that the therapeutic effect of central stimulants is often unsustainable and reduced dosage often causes rapid return of symptoms[ 32 ]; (3) Unacceptable side effects in some patients. Common side effects of central stimulants include headache, loss of appetite, weight loss, mouth dryness, palpitations, insomnia, gastrointestinal infections, and abnormally elevated blood pressure[ 33 , 34 ]; (4) Central stimulants such as methylphenidate often fail to improve patients’ comorbidities. ADHD patients often have a variety of mental disorders or emotional symptoms.…”

Section: Important Neuropsychotherapy Strategies For Adhd: Mindfulnes...mentioning

confidence: 99%

Convergence mechanism of mindfulness intervention in treating attention deficit hyperactivity disorder: Clues from current evidence

Xu¹,

Wang²,

Wan³

et al. 2022

WJCC

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This paper reviews the underlying evidence for various aspects of the convergence mechanism of mindfulness intervention in attention deficit hyperactivity disorder (ADHD). There may be compatibility among various ADHD remission models and the therapeutic mechanism of mindfulness intervention in ADHD may be mainly via the convergence mechanism. However, neuroimaging-based analysis of the mechanisms of mindfulness intervention in treating ADHD is lacking. Differences in the efficacy of various subtypes of mindfulness intervention, and corresponding specific imaging changes need further investigation. Future research may focus on the neuroimaging features of specific mindfulness intervention subtypes.

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Section: Important Neuropsychotherapy Strategies For Adhd: Mindfulnes...mentioning

confidence: 99%

Convergence mechanism of mindfulness intervention in treating attention deficit hyperactivity disorder: Clues from current evidence

Xu¹,

Wang²,

Wan³

et al. 2022

WJCC

View full text Add to dashboard Cite

show abstract

“…ADHD is defined as a mental health disability, which usually begins before 12 years of age, and is characterised by three main symptoms: inattention, impulsivity and hyperactivity (without hyperactivity, the term ‘attention deficit disorder’ (ADD) may be used). The intensity of the symptoms tends to decrease with ageing, but in 40%–50% of people diagnosed with ADHD in childhood, symptoms may persist during adolescence and adulthood 4 5. Therefore, methylphenidate is also increasingly used in adults,4 which was considered as an ‘off-label’ group for several years.…”

Section: Introductionmentioning

confidence: 99%

“…The intensity of the symptoms tends to decrease with ageing, but in 40%–50% of people diagnosed with ADHD in childhood, symptoms may persist during adolescence and adulthood 4 5. Therefore, methylphenidate is also increasingly used in adults,4 which was considered as an ‘off-label’ group for several years. In patients with ADD or ADHD, methylphenidate improves the balance between concentration and distraction and decrease hyperactivity 6.…”

Section: Introductionmentioning

confidence: 99%

General practice database on mortality in adults on methylphenidate: cohort study

2022

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ObjectivesMethylphenidate is a ‘prescription only’ drug against attention disorders which is increasingly used by adults. We investigated whether methylphenidate in adults was associated with an increased risk of psychiatric events such as depression, and suicide attempt and overall mortality.DesignA population-based matched cohort design.SettingThe Integrated Primary Care Information system, a general practitioners (GP) database in the Netherlands with a source population of 2.5 million inhabitants.ParticipantsDuring the study period between 1 June 1996 and 1 January 2018, 8905 adults started methylphenidate and were matched to 10 non-users on sex, age, GP practice and ad prescription date. The total study population consisted of 97 198 participants.Main outcome measuresSerious psychiatric events such as depression and suicide attempts, and overall mortality.AnalysesRisks of development of each event during the use of methylphenidate were expressed as HR with 95% CI, adjusted for relevant confounders with methylphenidate as a time-dependent determinant. Additional adjustment was performed for the intervention (‘intention-to-treat’).ResultsAlthough during follow-up, the unadjusted risks of depression and suicide attempt were strongly increased in users, depression and psychosis became non-significant after adjustment for alcohol-abuse and substance-abuse and psychiatric disease in the medical history and after adjustment for ‘intention-to-treat’. However, the risk of suicide attempts remained significantly increased after full adjustment (HR 2.0; 95% CI 1.1 to 3.6), and was highest in women and in participants within the age-group of 18–40 years. The unadjusted risk of overall mortality was strongly increased, but this lowered to a significant 30% risk increase (HR 1.3; 95% CI 1.1 to 1.6) after full adjustment.ConclusionThere is an increased risk of suicide attempts in adults up to 40 years of age after starting methylphenidate and this risk should be carefully considered before prescribing to this group.

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“…Systematic reviews of commonly used psychiatric drugs, particularly of antidepressants for depression (Jakobsen et al ., 2017 ; Munkholm et al ., 2019 ) and of central stimulants for attention deficit hyperactivity disorder (ADHD) (Storebø et al ., 2015 ; Punja et al ., 2016 ; Castells et al ., 2018 ; Cândido et al ., 2021 ), have highlighted potential problems with low generalisability of psychiatric drug trials. Methodological limitations include small sample sizes, short trial durations, restricted trial populations in terms of allowed psychiatric comorbidity, risk of withdrawal effects due to previous exposure to the drug of interest, and use of surrogates and rating scales rather than patient-relevant outcomes.…”

Section: Introductionmentioning

confidence: 99%

EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations

Boesen

Gøtzsche

Ioannidis

2021

Epidemiol Psychiatr Sci

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Aims The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) produce guidelines for the design of pivotal psychiatric drug trials used in new drug applications. It is unknown who are involved in the guideline development and what specific trial design recommendations they give. Methods Cross-sectional study of EMA Clinical Efficacy and Safety Guidelines and FDA Guidance Documents. Study outcomes: (1) guideline committee members and declared conflicts of interest; (2) guideline development and organisation of commenting phases; (3) categorisation of stakeholders who comment on draft and final guidelines according to conflicts of interest (‘industry’, ‘not-industry but with industry-related conflicts’, ‘independent’, ‘unclear’); and (4) trial design recommendations (trial duration, psychiatric comorbidity, ‘enriched design’, efficacy outcomes, comparator choice). Protocol registration https://doi.org/10.1101/2020.01.22.20018499 (27 January 2020). Results We included 13 EMA and five FDA guidelines covering 15 psychiatric indications. Eleven months after submission, the EMA had not processed our request regarding committee member disclosures. FDA offices draft the Guidance Documents, but the Agency is not in possession of employee conflicts of interest declarations because FDA employees generally may not hold financial interests (although some employees may hold interests up to $15,000). The EMA and FDA guideline development phases are similar; drafts and final versions are publicly announced and everybody can submit comments. Seventy stakeholders commented on ten guidelines: 38 (54%) ‘industry’, 18 (26%) ‘not-industry but with industry-related conflicts’, six (9%) ‘independent’ and eight (11%) ‘unclear’. They submitted 1014 comments: 640 (68%) ‘industry’, 243 (26%) ‘not-industry but with industry-related conflicts’, 44 (5%) ‘independent’ and 20 (2%) ‘unclear’ (67 could not be assigned to a specific stakeholder). The recommended designs were generally for trials of short duration; with restricted trial populations; allowing previous exposure to the drug; and often recommending rating scale efficacy outcomes. EMA mainly recommended three arm designs (both placebo and active comparators), whereas FDA mainly recommended placebo-controlled designs. There were also other important differences and FDA's recommendations regarding the exclusion of psychiatric comorbidity seemed less restrictive. Conclusions The EMA and FDA clinical research guidelines for psychiatric pivotal trials recommend designs that tend to have limited generalisability. Independent and non-conflicted stakeholders are underrepresented in the guideline development. It seems warranted with more active involvement of scientists and independent organisations without conflicts of interest in the guideline development process.

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Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults

Abstract: This is a repository copy of Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults.

Cited by 19 publications

References 113 publications

Convergence mechanism of mindfulness intervention in treating attention deficit hyperactivity disorder: Clues from current evidence

Convergence mechanism of mindfulness intervention in treating attention deficit hyperactivity disorder: Clues from current evidence

General practice database on mortality in adults on methylphenidate: cohort study

EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations

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