lisdexamfetamine-dimesylate and Mood-Disorders

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.

Topics: Antidepressive Agents; Anxiety Disorders; Binge-Eating Disorder; Clinical Trials as Topic; Comorbidity; Feeding Behavior; Female; Humans; Hydrocortisone; Lisdexamfetamine Dimesylate; Male; Metabolic Syndrome; Models, Psychological; Mood Disorders; Night Eating Syndrome; Obesity; Phototherapy; Prevalence; Psychotherapy; Relaxation Therapy; Selective Serotonin Reuptake Inhibitors; Serotonin; Sex Distribution; Sleep Wake Disorders; Stress, Psychological

To describe symptom rebound in children with ADHD treated with lisdexamfetamine dimesylate (LDX) or placebo.. During a 4-week, randomized, double-blind, placebo-controlled trial of LDX, parents/caregivers completed the Conners' Parent Rating Scale-Revised: Short Form symptom rating scale throughout the day. Response, rebound, and emotional lability (EL) were assessed post hoc based on predefined criteria.. Most participants given LDX ( n = 207) were responders throughout the day (50.7%-55.6%) versus placebo ( n = 72; 11.1%-22.2%). A total of seven (3.4%) LDX participants showed rebound in the afternoon and/or evening versus seven (9.7%) with placebo. In both groups, most incidences of rebound occurred in the evening. EL (mean) was higher in LDX rebounders and nonresponders (range = 4.2-9.0) versus LDX responders (range = 1.3-1.6) and versus placebo rebounders (range = 0.7-1.9).. ADHD symptom rebound occurred in few participants (3.3%) given LDX (accompanied by clinically significant EL). Overall, more participants given LDX versus placebo responded throughout the day.

Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Dextroamphetamine; Double-Blind Method; Drug Administration Schedule; Emotions; Female; Humans; Lisdexamfetamine Dimesylate; Male; Mood Disorders; Parents; Treatment Outcome

To evaluate the effect of lisdexamfetamine dimesylate (LDX) on emotional lability (EL) in children with ADHD.. Post hoc analyses of a placebo-controlled trial of LDX-stratified children (aged 6-12 years) with ADHD to prominent and not prominent EL at baseline (score >3 or ≤3, respectively, on Conners' Parent Rating Scale [CPRS] items of anger, loss of temper, and irritability). Efficacy was assessed by change in CPRS EL scores and ADHD Rating Scale-IV (ADHD-RS-IV) total and subscale scores. Safety measures included treatment-emergent adverse events (TEAEs).. LDX showed improvement versus placebo (p < .0005) for EL item least squares (LS) mean change scores at endpoint and throughout the day. At baseline, 138 and 73 participants randomized to LDX treatment and having baseline and endpoint CPRS scores were categorized with CPRS-derived prominent and not prominent baseline EL, respectively; 41 and 31 participants randomized to placebo were categorized with CPRS-derived prominent and not prominent baseline EL, respectively. ADHD-RS-IV total and subscale scores decreased with LDX regardless of baseline EL severity. TEAEs included decreased appetite, insomnia, upper abdominal pain, headache, and irritability.. EL and ADHD symptoms improved with LDX regardless of baseline EL symptom severity. LDX demonstrated a safety profile consistent with long-acting psychostimulant use.

Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Dextroamphetamine; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Emotions; Female; Humans; Lisdexamfetamine Dimesylate; Male; Mood Disorders; Parents; Personality Assessment; Treatment Outcome