RESUMEN
Eating disorders (EDs) are a non-heterogeneous group of illnesses with significant physical and mental comorbidity and mortality associated with maladaptive coping. With the exception of lisdexamfetamine (Vyvanse) for binge eating disorder, no medications have been effective for the core symptoms of ED. ED requires a multimodal approach. Complementary and integrative medicine (CIM) can be helpful as an adjunct. The most promising CIM interventions are traditional yoga, virtual reality, eye movement desensitization and reprocessing, Music Therapy, and biofeedback/neurofeedback.
Asunto(s)
Terapia por Acupuntura , Anorexia Nerviosa , Arteterapia , Trastorno por Atracón , Bulimia Nerviosa , Trastornos de Alimentación y de la Ingestión de Alimentos , Medicina Integrativa , Neurorretroalimentación , Realidad Virtual , Yoga , Humanos , Adolescente , Bulimia Nerviosa/terapia , Espiritualidad , Trastorno por Atracón/diagnóstico , Dimesilato de Lisdexanfetamina , Fototerapia , Anorexia Nerviosa/diagnósticoRESUMEN
Professional observers are independent persons who have in-depth knowledge of both children's normal behaviour and development and of ADHD, and who take a multidisciplinary approach to ADHD in their daily work. The observation must be geared to the specific problem with the child in question
Asunto(s)
Humanos , Niño , Adolescente , Trastorno por Déficit de Atención con Hiperactividad/terapia , Terapia Cognitivo-Conductual , Terapias de Arte Sensorial , Déficit de la Atención y Trastornos de Conducta Disruptiva/tratamiento farmacológico , Ácidos Grasos Insaturados/uso terapéutico , Dimesilato de Lisdexanfetamina , Clorhidrato de Atomoxetina , Colorantes de Alimentos/efectos adversos , Melatonina , MetilfenidatoRESUMEN
Lisdexamfetamine dimesylate (lisdexamfetamine; Elvanse®; Tyvense®), an orally-active dexamfetamine prodrug, is indicated in the EU for the treatment of attention-deficit hyperactivity disorder (ADHD) in children aged ≥ 6 years (including adolescents) when the response to previous methylphenidate (MPH) treatment is clinically inadequate. The original approval of the drug was based on the results of phase III trials in children and adolescents with ADHD who had an inadequate response to previous pharmacotherapy (e.g. MPH) or were treatment naïve. In these studies, short-term treatment with flexibly-dosed lisdexamfetamine demonstrated greater efficacy than atomoxetine, based on a prospective comparison, and osmotic-release oral system (OROS)-MPH, based on a post hoc comparison. Improvements in ADHD symptoms were accompanied by improvements in health-related quality of life and functioning that were maintained as long as treatment with lisdexamfetamine was continued in a long-term extension of one of these trials. In subsequent phase IV head-to-head studies in adolescents with ADHD and an inadequate response to previous pharmacotherapy, lisdexamfetamine demonstrated greater efficacy than OROS-MPH when both medications were force-titrated, but not when they were flexibly-titrated. Lisdexamfetamine was generally well tolerated, with an adverse event profile (e.g. decreased appetite, headache, weight reduction, insomnia and irritability) typical of that reported for other stimulants. Thus, lisdexamfetamine provides an alternative option for the treatment of children and/or adolescents with ADHD who have not responded adequately to previous ADHD pharmacotherapies.
Asunto(s)
Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/farmacocinética , Estimulantes del Sistema Nervioso Central/uso terapéutico , Dimesilato de Lisdexanfetamina/farmacocinética , Dimesilato de Lisdexanfetamina/uso terapéutico , Estimulantes del Sistema Nervioso Central/administración & dosificación , Estimulantes del Sistema Nervioso Central/efectos adversos , Niño , Dextroanfetamina/farmacología , Dextroanfetamina/uso terapéutico , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Aprobación de Drogas , Europa (Continente) , Humanos , Dimesilato de Lisdexanfetamina/administración & dosificación , Dimesilato de Lisdexanfetamina/efectos adversos , Metilfenidato/farmacología , Metilfenidato/uso terapéutico , Calidad de Vida , Resultado del TratamientoRESUMEN
Binge-eating disorder (BED) and night-eating syndrome (NES) are two forms of disordered eating associated with overweight and obesity. While these disorders also occur in nonobese persons, they seem to be associated with weight gain over time and higher risk of diabetes and other metabolic dysfunction. BED and NES are also associated with higher risk of psychopathology, including mood, anxiety, and sleep problems, than those of similar weight status without disordered eating. Treatments are available, including cognitive behavior therapy (CBT), interpersonal psychotherapy, lisdexamfetamine, and selective serotonin reuptake inhibitors (SSRIs) for BED; and CBT, SSRIs, progressive muscle relaxation, and bright light therapy for NES.
Asunto(s)
Trastorno por Atracón/complicaciones , Síndrome de Alimentación Nocturna/complicaciones , Obesidad/etiología , Antidepresivos/uso terapéutico , Trastornos de Ansiedad/complicaciones , Trastornos de Ansiedad/terapia , Trastorno por Atracón/epidemiología , Trastorno por Atracón/psicología , Trastorno por Atracón/terapia , Ensayos Clínicos como Asunto , Comorbilidad , Conducta Alimentaria , Femenino , Humanos , Hidrocortisona/fisiología , Dimesilato de Lisdexanfetamina/uso terapéutico , Masculino , Síndrome Metabólico/complicaciones , Síndrome Metabólico/fisiopatología , Modelos Psicológicos , Trastornos del Humor/complicaciones , Trastornos del Humor/terapia , Síndrome de Alimentación Nocturna/epidemiología , Síndrome de Alimentación Nocturna/psicología , Síndrome de Alimentación Nocturna/terapia , Obesidad/fisiopatología , Obesidad/prevención & control , Fototerapia , Prevalencia , Psicoterapia , Terapia por Relajación , Serotonina/fisiología , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Distribución por Sexo , Trastornos del Sueño-Vigilia/complicaciones , Trastornos del Sueño-Vigilia/terapia , Estrés Psicológico/complicaciones , Estrés Psicológico/fisiopatologíaRESUMEN
BACKGROUND: Chronic amphetamine treatment decreases cocaine consumption in preclinical and human laboratory studies and in clinical trials. Lisdexamfetamine is an amphetamine prodrug in which L-lysine is conjugated to the terminal nitrogen of d-amphetamine. Prodrugs may be advantageous relative to their active metabolites due to slower onsets and longer durations of action; however, lisdexamfetamine treatment's efficacy in decreasing cocaine consumption is unknown. METHODS: This study compared lisdexamfetamine and d-amphetamine effects in rhesus monkeys using two behavioral procedures: (1) a cocaine discrimination procedure (training dose = 0.32mg/kg cocaine, i.m.); and (2) a cocaine-versus-food choice self-administration procedure. RESULTS: In the cocaine-discrimination procedure, lisdexamfetamine (0.32-3.2mg/kg, i.m.) substituted for cocaine with lower potency, slower onset, and longer duration of action than d-amphetamine (0.032-0.32mg/kg, i.m.). Consistent with the function of lisdexamfetamine as an inactive prodrug for amphetamine, the time course of lisdexamfetamine effects was related to d-amphetamine plasma levels by a counter-clockwise hysteresis loop. In the choice procedure, cocaine (0-0.1mg/kg/injection, i.v.) and food (1g banana-flavored pellets) were concurrently available, and cocaine maintained a dose-dependent increase in cocaine choice under baseline conditions. Treatment for 7 consecutive days with lisdexamfetamine (0.32-3.2mg/kg/day, i.m.) or d-amphetamine (0.032-0.1mg/kg/h, i.v.) produced similar dose-dependent rightward shifts in cocaine dose-effect curves and decreases in preference for 0.032mg/kg/injection cocaine. CONCLUSIONS: Lisdexamfetamine has a slower onset and longer duration of action than amphetamine but retains amphetamine's efficacy to reduce the choice of cocaine in rhesus monkeys. These results support further consideration of lisdexamfetamine as an agonist-based medication candidate for cocaine addiction.
Asunto(s)
Trastornos Relacionados con Cocaína/tratamiento farmacológico , Inhibidores de Captación de Dopamina/farmacología , Dimesilato de Lisdexanfetamina/farmacología , Animales , Conducta de Elección/efectos de los fármacos , Cocaína/administración & dosificación , Condicionamiento Operante/efectos de los fármacos , Dextroanfetamina/farmacología , Discriminación en Psicología/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Evaluación Preclínica de Medicamentos , Preferencias Alimentarias/efectos de los fármacos , Macaca mulatta , Masculino , Autoadministración , Factores de TiempoRESUMEN
BACKGROUND AND OBJECTIVES: The retrospective comparison of test and reference treatment arms in a randomized prospective clinical trial is potentially useful in economic modeling seeking to assess the cost effectiveness of alternative therapies. METHODS: To enhance the credibility of such retrospective comparisons, we propose the application of the following adjustments to significance levels obtained from standard statistical methodology: (1) a significance test for the lower bound of the 95 % confidence interval for the observed difference, (2) a conservative Bonferroni method of adjustment for multiple comparisons, (3) an adjusted p-value calculated using Scheffe's single-step method, and (4) Bayesian 95 % credibility intervals with a prior centered at zero. RESULTS: These adjustments were applied to data from a randomized double-blind concurrent trial (SPD489-325) that established the efficacy and safety of lisdexamfetamine dimesylate (LDX) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Prospectively planned analyses demonstrated that the reduction in the symptoms of ADHD was significantly greater than placebo in patients treated with either LDX or the reference treatment, osmotic-release oral system methylphenidate (OROS-MPH). Retrospective analyses showed that the improvement in the symptoms of ADHD was greater in patients treated with LDX than OROS-MPH. We now show that this observation remained significant after the application of the four statistical penalties. CONCLUSIONS: By adjusting the significance level, it is possible to compare quantitatively such retrospective results with prospectively defined comparisons. However, the qualitative level of such retrospective evidence should remain secondary to that obtained from prospectively specified comparisons in a randomized clinical trial.
Asunto(s)
Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Adolescente , Teorema de Bayes , Niño , Dextroanfetamina/uso terapéutico , Método Doble Ciego , Humanos , Dimesilato de Lisdexanfetamina , Estudios RetrospectivosRESUMEN
We evaluated the effects of white noise played through headphones on off-task behavior, percentage of items completed, and percentage of items completed correctly for 3 students with attention deficit hyperactivity disorder (ADHD). Headphones plus white noise were associated with decreases in off-task behavior relative to baseline and headphones-only (no white noise) control conditions. Little change in academic responding occurred across conditions for all participants.
Asunto(s)
Logro , Trastorno por Déficit de Atención con Hiperactividad/psicología , Trastorno por Déficit de Atención con Hiperactividad/rehabilitación , Aprendizaje , Ruido , Estimulación Acústica/métodos , Anfetaminas/uso terapéutico , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/farmacología , Niño , Dextroanfetamina/uso terapéutico , Femenino , Humanos , Aprendizaje/efectos de los fármacos , Dimesilato de Lisdexanfetamina , MasculinoRESUMEN
Lisdexamfetamine dimesylate, which consists of L-lysine covalently bound to D-amfetamine, is the first prodrug for treating ADHD. Its metabolic conversion to yield D-amfetamine by rate-limited, enzymatic hydrolysis is unusual because it is performed by peptidases associated with red blood cells. Other stimulants shown to be effective in managing ADHD include D-amfetamine, methylphenidate and modafinil. All have the potential for misuse or recreational abuse. The discriminative and reinforcing effects of these compounds were determined in rats using a 2-choice, D-amfetamine (0.5 mg/kg, i.p.)-cued drug-discrimination test, and by substitution for intravenous cocaine in self-administration. Lisdexamfetamine (0.5-1.5 mg/kg [D-amfetamine base], p.o.) generalised to saline when tested 15 min post-dosing, but dose-dependently generalised to d-amfetamine at 60 min. At 120 min, its D-amfetamine-like effects were substantially diminished. At 15 min, methylphenidate (3.0-10 mg/kg, p.o.) and D-amfetamine (0.1-1.5 mg/kg, p.o.) dose-dependently generalised to the intraperitoneal D-amfetamine cue. Switching to the intraperitoneal route reduced the interval required for lisdexamfetamine to be recognised as D-amfetamine-like, but did not alter its potency. Switching to intraperitoneal injection increased the potency of methylphenidate and D-amfetamine by 3.4× and 2.2×, respectively. Modafinil (50-200 mg/kg, i.p.) generalised partially, but not fully, to d-amfetamine. Methylphenidate (0.1, 0.3, 1.0 mg/kg/injection, i.v.) maintained robust self-administration at the 2 highest doses. Neither lisdexamfetamine (0.05, 0.15 or 0.5 mg/kg/injection [D-amfetamine base], i.v.) nor modafinil (0.166, 0.498 or 1.66 mg/kg/injection, i.v.) served as reinforcers. The results reveal important differences between the profiles of these stimulants. Lisdexamfetamine did not serve as a positive reinforcer in cocaine-trained rats, and although it generalised fully to D-amfetamine, its discriminative effects were markedly influenced by its unusual pharmacokinetics.