Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder
Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression; Excessive Daytime Sleepiness
Intervention: Driving Simulator Testing (Behavioral); Mirtazapine Treatment (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s): Colin M. Shapiro, MBBCh, PhD, Principal Investigator, Affiliation: University Health Network, Toronto Sharon A. Chung, PhD, Study Director, Affiliation: University Health Network, Toronto
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.
Clinical Details
Official title: Antidepressant Response to a Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Driving performance on the driving simulator
Secondary outcome: Ability to maintain wakefulness
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.
Eligibility
Minimum age: 25 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Fulfilling DSM-IV criteria for Major Depressive Disorder
- Score of Hamilton Rating Scale for Depression (HDRS-17) > 17
- Patient to be prescribed mirtazapine (Remeron) as determined by physician
- Subject has no known clinically significant abnormal vital signs or other clinical
findings at screening.
- Patients should have a driving license for more than 3 years and drive over 15,000 km
year.
- Females of childbearing potential must willingly use effective birth control.
Exclusion Criteria:
- Night shift workers.
- A history or present condition of: Bipolar Disorder or Depressive Disorder not
Otherwise Specified,Schizophrenia or other psychotic disorders (according to DSM-IV),
Schizotypal or Borderline personality disorder, Organic mental disorders
- A present condition of: Anxiety Disorders (according to DSM-IV), Eating Disorders,
Postpartum Depression
- Epilepsy or a history of seizure disorder or ever received treatment with
anticonvulsant medication for epilepsy or seizures
- PSG recording of an extremely abnormal sleep EEG (other than that which would be
expected with depression)
- Alcohol or substance abuse (according to DSM-IV) during the last 6months prior to
baseline.
- Any physical disease, which may explain the symptoms of depression.
- Any chronic physical disease, which is not stabilized.
Locations and Contacts
University Health Network, Toronto, Ontario M5T 2S8, Canada
Additional Information
Related publications: Bulmash EL, Moller HJ, Kayumov L, Shen J, Wang X, Shapiro CM. Psychomotor disturbance in depression: assessment using a driving simulator paradigm. J Affect Disord. 2006 Jul;93(1-3):213-8. Epub 2006 Mar 7.
Starting date: April 2003
Last updated: October 5, 2006
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