Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385437
Status:
COMPLETED
Last Update Posted:
2006-10-09
First Post:
2006-10-05
Brief Title:
Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Antidepressant Response to a Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 mirtazapines 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
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 mirtazapines 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None