Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder
Condition: Depression; Excessive Daytime Sleepiness
MeSH terms: Disorders of Excessive Somnolence; Sleepiness; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This concurrent, two-part study will:

      I) Using overnight sleep recordings, evaluate the short- and long-term sleep-promoting
      effects of the antidepressant mirtazapine (Remeron) in patients who have been prescribed this
      medication for major depressive disorder and sleep disruption.

      II) Investigate the psychomotor performance of depressed patients using driving simulation
      testing before and during treatment with mitrazapine.
    

Detailed description: 
      In the treatment of depression, the role of sleep is important as there are mutual
      relationships between mood disorder and sleep disorders. Over 80% of major depressive
      disorder (MDD) patients report sleeping problems. Depression can strongly impair cognitive
      functioning and daytime alertness. (Mirtazapine (Remeron) is an antidepressant and
      sleep-promoting agent that has been available in Canada for a few years. However, research
      investigating the effects of mirtazapine on sleep is limited and it is not known what are the
      short- and long-term changes in sleep architecture associated with this drug and if daytime
      performance is affected.

      Rationale:

      The co-existence of depression and sleep difficulties are very common. Mirtazapine is
      marketed as a single modality of treatment for both depression and impaired sleep. As a sleep
      clinic in a psychiatry department, a single modality of treatment for depressive and sleep
      disorders is preferred by patients and can help improve compliance to treatment. However,
      there are only 7 published studies investigating the effects of mirtazapine and sleep and
      these have significant limitations. None of these studies have objectively examined
      mirtazapine's short- and long-term on sleep architecture and daytime function (daytime
      sleepiness, alertness, driving performance) in depressed patients. This study will address
      these issues.

      Hypothesis:

      I) Mirtazapine will produce both immediate and long- improvement effects on sleep in patients
      with major depressive disorders. There may be impairments in alertness for the first two days
      after starting treatment but daytime alertness will recover after one week.

      II) Patients treated with mitrazapine will show a rapid, initial improvement in driving
      performance with recovery of sleep and slower, further improvement as treatment of their
      depression translates into better sleep quality as well as improvements in attention,
      alertness and concentration.

      Study Design:

      This pilot proposal is a two-part longitudinal, open-label clinical study with consecutive
      enrollment of subjects.

      This research study will take place in conjunction with normal clinical practice. Patients
      with depression and sleep disorders are commonly seen in our sleep clinic and mirtazapine is
      one of several antidepressants that is prescribed by our clinicians. In this study, we will
      follow a group of patients who have been prescribed mirtazapine by one of our clinic
      physicians and who meet the inclusion and exclusion listed below. There will be an additional
      number of sleep studies (10 total versus the usual 2 or 3) performed; the usual daytime
      testing will be conducted as part of the standard of care (Multiple Sleep Latency Test (MSLT)
      and Maintenance of Wakefulness Test (MWT)); we will administer additional questionnaires to
      assess subjective sleepiness, alertness and fatigue; and, driving simulator testing will be
      conducted in accordance with our normal standard of care.
    

Intervention name(s): Driving Simulator Testing; Mirtazapine Treatment
Intervention type(s): Behavioral; Drug
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Driving safety; maintenance of wakefulness test; major depressive disorder; mirtazapine