title: The effect of lisdexamfetamine dimesylate on body weight, metabolic parameters, and attention deficit hyperactivity disorder symptomatology in adults with bipolar I/II disorder.
abstract: OBJECTIVE
  We primarily sought to determine the effect of adjunctive lisdexamfetamine dimesylate (LDX) on anthropometric and metabolic parameters. Our secondary aim was to evaluate the effect of LDX on attention deficit hyperactivity disorder (ADHD) symptom severity in adults with bipolar I/II disorder.
  
  
  METHODS
  Forty-five stable adults (i.e., non-rapid cycling, absence of clinically significant hypo/manic symptoms) with bipolar I/II disorder and comorbid ADHD were enrolled in a phase IV, 4-week, flexible dose, open-label study of adjunctive LDX. All subjects were initiated at 30 mg/day of adjunctive LDX for the first week with flexible dosing (i.e., 30-70 mg/day) between weeks 2 and 4.
  
  
  RESULTS
  Of the 45 subjects enrolled, 40 received adjunctive LDX (mean dose = 60 ± 10 mg/day). A statistically significant decrease from baseline to endpoint was evident in weight (p < 0.001), body mass index (p < 0.001), fasting total cholesterol (p = 0.011), low density lipoprotein cholesterol (p = 0.044), high density lipoprotein cholesterol (p = 0.015) but not triglycerides, or blood glucose. Significant reductions were also observed in leptin (p = 0.047), but not in ghrelin, adiponectin, or resistin levels. Diastolic blood pressure and pulse increased significantly over time but on average remained within the normal range (p < 0.001). There was a significant reduction from baseline to endpoint in the total score of the ADHD Self-Report Scale. Significant improvement from baseline to endpoint was also observed in the Montgomery-Åsberg Depression Rating Scale total score as well as the Clinical Global Impression Severity and Improvement score.
  
  
  CONCLUSIONS
  Short-term adjunctive LDX treatment was well tolerated by this sample of adults with stable bipolar I/II disorder. Lisdexamfetamine dimesylate offered beneficial effects on body weight, body mass index and several metabolic parameters. In addition to demonstrating short-term (i.e., 4 weeks) safety and tolerability, beneficial effects of LDX were also observed in mitigating depressive and ADHD symptom severity.
authors.affiliation: Institute of Medical Science, University of Toronto, Toronto, Canada; Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada; Department of Pharmacology, University of Toronto, Toronto, Canada; Department of Psychiatry, University Health Network, Toronto, Canada.
authors.forename: Roger S
authors.initials: RS
authors.lastname: McIntyre
authors.forename: Mohammad
authors.initials: M
authors.lastname: Alsuwaidan
authors.forename: Joanna K
authors.initials: JK
authors.lastname: Soczynska
authors.forename: Isaac
authors.initials: I
authors.lastname: Szpindel
authors.forename: Timothy S
authors.initials: TS
authors.lastname: Bilkey
authors.forename: Doron
authors.initials: D
authors.lastname: Almagor
authors.forename: Hanna O
authors.initials: HO
authors.lastname: Woldeyohannes
authors.forename: Alissa M
authors.initials: AM
authors.lastname: Powell
authors.forename: Danielle S
authors.initials: DS
authors.lastname: Cha
authors.forename: Laura Ashley
authors.initials: LA
authors.lastname: Gallaugher
authors.forename: Sidney H
authors.initials: SH
authors.lastname: Kennedy
mesh_terms: D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000378:metabolism* / Q000523:psychology; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000378:metabolism* / Q000523:psychology; D001835:Body Weight / Q000187:drug effects* / Q000502:physiology; D003913:Dextroamphetamine / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000069478:Lisdexamfetamine Dimesylate; D003913:Dextroamphetamine
keywords: ADHD; BMI; bipolar disorder; leptin; lisdexamfetamine dimesylate; metabolic