title: A pilot double-blind placebo-controlled trial of low-dose pramipexole in sleep-related eating disorder.
abstract: Sleep-related eating disorder (SRED) is characterized by recurrent arousals from sleep associated with compulsive ingestion of food. No controlled therapeutic trials are available for SRED. We assessed the safety, tolerability and efficacy of pramipexole, a dopamine D3-receptor agonist, in the treatment of SRED. Eleven consecutive patients with SRED in the absence of concurrent daytime eating disorders underwent actigraphic recording and subjective sleep diary evaluation for a week before and every week for 2 weeks of treatment with pramipexole 0.18-0.36 mg or placebo, administered in a double-blind crossover randomized sequence. The primary outcomes of the trial were actigraphic measures of night sleep parameters (sleep efficiency, motor activity mean and median, number and duration of wake episodes), secondary outcomes were the number of good sleep nights/weekly, number and duration of nocturnal awakenings/night, and visual analogue preference score. Pramipexole was well tolerated without any patient withdrawing from the study. Pramipexole reduced night-time activity median (P = 0.02) and increased the number of nights of good sleep/week (P = 0.02). All other measurements remained unaffected. Pramipexole at low doses was well tolerated, improving some measures of sleep quality and reducing median night activity in SRED. Further studies with higher dosages and for longer time-periods are warranted.
authors.affiliation: Department of Neurological Sciences, University of Bologna, Bologna, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Provini
authors.forename: F
authors.initials: F
authors.lastname: Albani
authors.forename: R
authors.initials: R
authors.lastname: Vetrugno
authors.forename: L
authors.initials: L
authors.lastname: Vignatelli
authors.forename: C
authors.initials: C
authors.lastname: Lombardi
authors.forename: G
authors.initials: G
authors.lastname: Plazzi
authors.forename: P
authors.initials: P
authors.lastname: Montagna
mesh_terms: D000328:Adult; D000975:Antioxidants / Q000627:therapeutic use*; D052160:Benzothiazoles; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D001068:Feeding and Eating Disorders / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000187:drug effects; D010865:Pilot Projects; D017286:Polysomnography / Q000379:methods; D000077487:Pramipexole; D012189:Retrospective Studies; D012893:Sleep Wake Disorders / Q000150:complications / Q000188:drug therapy*; D013844:Thiazoles / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000975:Antioxidants; D052160:Benzothiazoles; D013844:Thiazoles; D000077487:Pramipexole