title: Doxepin and cognitive behavioural therapy for insomnia in patients with Parkinson's disease -- a randomized study.
abstract: BACKGROUND
  Although a variety of pharmacologic and non-pharmacologic treatments are effective for insomnia in the general population, insomnia in Parkinson's disease differs in important ways and may need different treatments. No studies have conclusively demonstrated effective insomnia treatments in Parkinson's disease.
  
  
  METHODS
  We conducted a three-arm six-week randomized pilot study assessing non-pharmacologic treatment (cognitive behavioural therapy with bright light therapy) or doxepin (10 mg daily), compared to an inactive placebo in Parkinson's patients with insomnia. Sleep outcomes included insomnia scales, clinical global impression, sleep diaries and actigraphy. Secondary outcomes included motor severity, fatigue, depression and quality of life.
  
  
  RESULTS
  18 patients were randomized, 6 to each group. Compared to placebo, doxepin improved the Insomnia Severity Index (-9 ± 5.4 vs. -2 ± 3.9, p = 0.03), the SCOPA-night score (-5.2 ± 1.5 vs. -2.3 ± 2.8, p = 0.049), the Pittsburgh Sleep Quality Index-sleep disturbances subscale (-0.5 ± 0.5 vs 0.2 ± 0.4, p = 0.02), and both patient and examiner-rated clinical global impression of change (1.7 ± 0.8 vs. 0.5 ± 0.8, p = 0.03 and 1.4 ± 0.5 vs. 0.3 ± 0.5, p = 0.003). On secondary outcomes doxepin reduced the fatigue severity scale (p = 0.02) and improved scores on the Montreal Cognitive Assessment (p = 0.007). Non-pharmacological treatment reduced the Insomnia Severity Index (-7.8 ± 3.8 vs. -2.0 ± 3.9, p = 0.03), and the examiner-reported clinical global impression of change (p = 0.006), but was associated with decline in Parkinson Disease Questionnaire-39. There were no changes in other primary and secondary outcomes, including actigraphy outcomes. Adverse events were comparable in all groups.
  
  
  CONCLUSIONS
  Doxepin and non-pharmacologic treatment substantially improved insomnia in Parkinson's disease. These potential benefits must be replicated in a full confirmatory randomized controlled trial.
authors.affiliation: Department of Neurology, McGill University, Montreal General Hospital, Montreal, Quebec, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Rios Romenets
authors.forename: L
authors.initials: L
authors.lastname: Creti
authors.forename: C
authors.initials: C
authors.lastname: Fichten
authors.forename: S
authors.initials: S
authors.lastname: Bailes
authors.forename: E
authors.initials: E
authors.lastname: Libman
authors.forename: A
authors.initials: A
authors.lastname: Pelletier
authors.forename: R B
authors.initials: RB
authors.lastname: Postuma
mesh_terms: D056044:Actigraphy; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D004316:Doxepin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000150:complications*; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy / Q000209:etiology / Q000534:rehabilitation; D016896:Treatment Outcome
chemical_list: D000929:Antidepressive Agents, Tricyclic; D004316:Doxepin