Lisdexamfetamine Dimesylate Augmentation in Adults With Persistent Executive Dysfunction After Partial or Full Remission of Major Depressive Disorder

Madhoo, Manisha; Keefe, Richard S.E.; Roth, Robert M.; Sambunaris, Angelo; Wu, James X.; Trivedi, Madhukar H.; Anderson, Colleen; Lasser, Robert

doi:10.1038/npp.2013.334

Cited by 67 publications

(59 citation statements)

References 44 publications

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“…Em 2011, Madhoo et al 22 Macedo et al 25 realizaram em 2013 um trabalho experimental com modelo animal, cujo objetivo era testar efeitos crônicos da administração de LDX sobre a locomoção de ratos, investigar as alterações oxidativas induzidas pela mesma no córtex pré-frontal, hipocampo e corpo estriado dos animais e testar a eficácia do lítio quanto à prevenção e/ou reversão da hiperlocomoção induzida pela droga. O estudo demonstrou que a administração crônica de LDX induz hiperlocomoção, tendo considerado tal achado como um modelo animal de mania.…”

Section: Resultsunclassified

“…Atualmente, são considerados apenas em casos resistentes ou sintomas residuais e sempre associados a algum AD 5,22,33 34 . O uso de LDX em TD, nos artigos selecionados por esta revisão, mostrou-se seguro e com taxas de efeitos adversos semelhantes ao placebo 5,22 . No texto que selecionamos para esta revisão, houve evidência estatística da melhora dos sintomas depressivos com a associação de LDX ao tratamento convencional do TD 5 .…”

Section: Transtorno Depressivounclassified

“…O prejuízo cognitivo ainda é apontado como uma potencial causa de presenteísmo no ambiente de trabalho 35 . O estudo de Madhoo et al 22 observou melhora da função cognitiva com a associação de LDX + AD em pacientes remitidos ou não do TD.…”

Section: Transtorno Depressivounclassified

“…Como fatores limitantes para esta revisão, temos o pouco tempo de acompanhamento dos estudos (4 a 8 semanas), com exceção de um 22 . Além disso, os estudos selecionados utilizaram metodologias, populações e severidades dos transtornos distintas, o que impossibilita a comparação dos resultados.…”

Section: Transtorno Depressivounclassified

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Lisdexanfetamina em transtornos de humor: uma revisão sistemática

Martins-da-Silva

Mosconi

Cury

et al. 2017

Debates em Psiquiatria

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ResumoTrata-se de uma revisão sistemática da literatura na base de dados MEDLINE para avaliar os efeitos e o perfil de segurança do uso de lisdexanfetamina (LDX) em pacientes com transtorno depressivo (TD) e transtorno afetivo bipolar (TAB), utilizando apenas medical subject headings (MeSH). Foram utilizados os seguintes termos para a busca: "depressive disorder" [MeSH] OR "bipolar disorder" [MeSH] AND "lisdexamfetamine dimesylate" [MeSH]. Somente artigos em português e inglês foram selecionados, sem limitação de período. Como critério de inclusão para o nosso estudo, utilizamos apenas artigos que observaram perfil dos efeitos do uso de LDX em pacientes que apresentavam transtornos do humor, podendo apresentar transtorno de déficit de atenção e hiperatividade comórbido ou não. Foram selecionados oito artigos, mas apenas cinco foram incluídos na síntese narrativa. Encontramos poucos dados sobre o uso de LDX em transtornos do humor, mas os resultados demonstram um uso possível para potencializar o tratamento e reduzir prejuízos cognitivos em pacientes com TD e na melhora dos parâmetros da síndrome metabólica em pacientes com TAB.Palavras-chave: Transtorno bipolar, transtorno depressivo, dimesilato de lisdexanfetamina. AbstractThe present study is a systematic review of the literature published in the MEDLINE database to evaluate the effects and safety profile of lisdexamfetamine (LDX) use in patients with depressive disorder (DD) and bipolar disorder (BD), using only medical subject headings (MeSH). The following terms were used: "depressive disorder" [MeSH] . We selected articles published in Portuguese and English only, with no publication date restrictions. As an inclusion criterion, only articles that observed the profile of effects of LDX use in patients with mood disorders, with or without comorbid attention deficit and hyperactivity disorder, were included. Eight papers were selected, but only five were included in the narrative synthesis. We found few data on the use of LDX in mood disorders, but the results demonstrate a possible use to potentiate treatment and reduce cognitive impairment in patients with DD, as well as to improve metabolic syndrome parameters in patients with BD.Keywords: Bipolar disorder, depressive disorder, lisdexamfetamine dimesylate. IntroduçãoO transtorno depressivo (TD) atinge de 10 a 15% da população ao ano 1-4 , sendo mais prevalente em mulheres, na proporção de 2:1 4 . Segundo a Organização Mundial de Saúde (OMS), a depressão é a segunda doença mais incapacitante do mundo, sendo a primeira quando consideramos o tempo vivido com a incapacitação no decorrer da vida 5 . Existe uma grande dificuldade na remissão completa dos seus sintomas, sendo o prejuízo cognitivo um dos principais sintomas residuais 6 . Atualmente, estima-se que 30 a 50% dos pacientes não se recuperam totalmente, existindo um consenso de que alguns déficits cognitivos persistiriam após a remissão dos outros sintomas 7 . Além disso, algumas medicações utilizadas para o tratamento do TD podem ter um impacto ne...

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Section: Resultsunclassified

Section: Transtorno Depressivounclassified

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Lisdexanfetamina em transtornos de humor: uma revisão sistemática

Martins-da-Silva

Mosconi

Cury

et al. 2017

Debates em Psiquiatria

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“…With evidence pointing to dysfunctional neuromodulation of the dorsolateral prefrontal cortex in relation to executive dysfunction in ADHD [52][53][54][55][56], it is not too much of a stretch to consider low hedonic tone as an affective correlate in ADHD explaining the lack of responsiveness to SSRIs in depression.…”

Section: Attention Deficit Hyperactivity Disorder (Adhd)mentioning

confidence: 99%

Hedonic Tone: A Bridge between the Psychobiology of Depression and its Comorbidities

A¹

2014

J Depress Anxiety

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paper will present the hypothesis that low hedonic tone and associated specific neurobiologic correlates predict the presence of ADHD in MDD, thus who is at risk for poorer outcomes with selective Serotonin Reuptake Inhibitors (SSRIs). Brain Regions and CircuitsEleven key areas of the brain have been highlighted in part by their specific neurotransmitter projections of which alteration in neurotransmitter innervation has been hypothesized to create disruptions in information processing and consequently specific psychological symptoms [2]. Linking each of these functional areas is a network of neuron projections or neurotransmitter pathways from the brainstem. It is posited that when a neurotransmitter-carrying neuron projects into a specific area, it has the capacity to modulate the physiological processes of the associated circuit [2]. Thus these pathways form the substrates that "tune" the neurons within each AbstractTreatment of Major Depressive Disorder (MDD), in many cases, offers less than optimal results, resulting in loss of function and remaining impairment. This is partially explained by the high prevalence of comorbid psychiatric illnesses that share common features, likely resulting in less than adequate treatment outcomes among patients receiving traditional psychiatric treatment.The term anhedonia does not sufficiently capture the complex and multifaceted reward-associated deficits seen in neuropsychiatric disorders. Deficits in reward-related processes can lead to behaviors that may appear to be the loss of interest or pleasure, and may preclude an individual from engaging in goal-oriented action. Investigators have identified a lifelong poor hedonic responsiveness, manifested as altered sensitivity to reinforcement, in patients with Attention Deficit Hyperactivity Disorder (ADHD), and suggest it as a common endophenotype for depression and the inattentive symptoms of ADHD. Research into the neurobiology of anhedonia has focused on the centers in the brain related to reward and motivation, and has identified the dopaminergic and associated circuits as playing a key role. Studies have shown that lesions in reward and motivation circuits result in anhedonia, and that decreased activation in the medial frontal cortex is believed to underlie abnormal positive affect processing in patients.In this paper, we propose that a specific phenotype of depression, which is more likely to be described as "treatment resistant" is associated with high risk of comorbidity with dysthymia, ADHD, and substance abuse, specifically cocaine abuse. We believe these patients experience a chronically lower hedonic tone that results in chronic anhedonia (as opposed to acute state anhedonia noted in a major depressive episode) related to unique pathophysiology and requiring treatment of the dopaminergic deficiency that characterizes its unique collection of comorbidities.

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Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating Disorder

et al. 2015

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IMPORTANCE Binge-eating disorder (BED), a public health problem associated with psychopathological symptoms and obesity and possibly with metabolic syndrome, lacks approved pharmacotherapies.OBJECTIVE To examine the efficacy and safety of lisdexamfetamine dimesylate, a dextroamphetamine prodrug, to treat moderate to severe BED. DESIGN, SETTING, AND PARTICIPANTSWe performed a randomized, double-blind, parallel-group, forced dose titration, placebo-controlled clinical trial at 30 sites from May 10, 2011, through January 30, 2012. Safety and intention-to-treat analyses included 259 and 255 adults with BED, respectively.INTERVENTIONS Lisdexamfetamine dimesylate at dosages of 30, 50, or 70 mg/d or placebo were provided to study participants (1:1:1:1). Dosages were titrated across 3 weeks and maintained for 8 weeks. We followed up participants for a mean (SD) of 7 (2) days after the last dose. MAIN OUTCOMES AND MEASURESWe assessed the change in binge-eating (BE) behaviors measured as days per week (baseline to week 11) with a mixed-effects model using transformed log (BE days per week) + 1. Secondary measures included BE cessation for 4 weeks. Safety assessments included treatment-emergent adverse events, vital signs, and change in weight. RESULTS At week 11, log-transformed BE days per week decreased with the 50-mg/d (least squares [LS] mean [SE] change, −1.49 [0.066]; P = .008) and 70-mg/d (LS mean [SE] change, −1.57 [0.067]; P < .001) treatment groups but not the 30-mg/d treatment group (LS mean [SE]change, −1.24 [0.067]; P = .88) compared with the placebo group. Nontransformed mean (SD) days per week decreased for placebo and the 30-, 50-, and 70-mg/d treatment groups by −3.3 (2.04), −3.5 (1.95), −4.1 (1.52), and −4.1 (1.57), respectively. The percentage of participants achieving 4-week BE cessation was lower with the placebo group (21.3%) compared with the 50-mg/d (42.2% [P = .01]) and 70-mg/d (50.0% [P < .001]) treatment groups. The incidence of any treatment-emergent adverse events was 58.7% for the placebo group and 84.7% for the combined treatment group. In the treatment groups, 1.5% of participants had serious treatment-emergent adverse effects. Events with a frequency of at least 5% and changes in heart rate were generally consistent with the known safety profile. The mean (SD) change in body weight was −0.1 (3.09), −3.1 (3.64), −4.9 (4.43), −4.9 (3.93), and −4.3 (4.09) kg for the placebo group, the 30-, 50-, and 70-mg/d treatment groups, and the combined treatment groups, respectively (P < .001 for each dose vs placebo group comparison in post hoc analysis). CONCLUSIONS AND RELEVANCEThe 50-and 70-mg/d treatment groups demonstrated efficacy compared with the placebo group in decreased BE days, BE cessation, and global improvement. The safety profile was generally consistent with previous findings in adults with attentiondeficit/hyperactivity disorder. Further investigation of lisdexamfetamine in BED is ongoing. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01291173

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Lisdexamfetamine Dimesylate Augmentation in Adults With Persistent Executive Dysfunction After Partial or Full Remission of Major Depressive Disorder

Cited by 67 publications

References 44 publications

Lisdexanfetamina em transtornos de humor: uma revisão sistemática

Lisdexanfetamina em transtornos de humor: uma revisão sistemática

Hedonic Tone: A Bridge between the Psychobiology of Depression and its Comorbidities

Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating Disorder

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