DepressionPhase 2NCT00385437
Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder
A Phase 2 study testing Driving Simulator Testing and Mirtazapine Treatment in people with Depression and Excessive Daytime Sleepiness, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Depression, Excessive Daytime Sleepiness
- What is being tested?
- Driving Simulator Testing and Mirtazapine Treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2003to Jun 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antidepressant Response to a Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder
This concurrent, two-part study will:
- 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.
Read the 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:
- 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.
- Conditions
- Depression, Excessive Daytime Sleepiness
- Being tested
- Driving Simulator Testing, Mirtazapine Treatment
- Keywords
- Driving safety, maintenance of wakefulness test, major depressive disorder, mirtazapine
- Medical subject headings
- Depression, Disorders of Excessive Somnolence, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving Simulator TestingBehavioural
Mirtazapine TreatmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving performance on the driving simulator
Secondary outcomes (1)
Ability to maintain wakefulness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startApr 2003
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 16 participants
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Organon
- Investigators
- Colin M. Shapiro, MBBCh, PhD, Principal investigator, University Health Network, TorontoSharon A. Chung, PhD, Study director, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385437
- Sponsor's protocol ID
- REB-03-0255-A
- Status last verified
- Feb 2006
- First submitted
- 5 Oct 2006
- Last updated
- 9 Oct 2006
- Results posted
- No
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. doi: 10.1016/j.jad.2006.01.015. Epub 2006 Mar 7.
PubMed 16522332Shen J, Chung SA, Kayumov L, Moller H, Hossain N, Wang X, Deb P, Sun F, Huang X, Novak M, Appleton D, Shapiro CM. Polysomnographic and symptomatological analyses of major depressive disorder patients treated with mirtazapine. Can J Psychiatry. 2006 Jan;51(1):27-34. doi: 10.1177/070674370605100106.
PubMed 16491981Shen J, Moller HJ, Wang X, Chung SA, Shapiro GK, Li X, Shapiro CM. Mirtazapine, a sedating antidepressant, and improved driving safety in patients with major depressive disorder: a prospective, randomized trial of 28 patients. J Clin Psychiatry. 2009 Mar;70(3):370-7. doi: 10.4088/jcp.08m04234. Epub 2009 Jan 13.
PubMed 19192466
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidepressant Response to a Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00385437
- Acronym / sponsor ID
- REB-03-0255-A
- Conditions
- Depression, Excessive Daytime Sleepiness
- Keywords
- Driving safety, maintenance of wakefulness test, major depressive disorder, mirtazapine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Organon
- Study start
- Apr 2003
- Study completion
- Jun 2004
- First posted
- 9 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This concurrent, two-part study will:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Driving Simulator Testing | Behavioural | – |
| Mirtazapine Treatment | Drug | – |
Primary outcome
Driving performance on the driving simulator
1 secondary outcome
Ability to maintain wakefulness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2006.
- Background: PubMed 16522332Bulmash 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. doi: 10.1016/j.jad.2006.01.015. Epub 2006 Mar 7.
- Results publication: PubMed 16491981Shen J, Chung SA, Kayumov L, Moller H, Hossain N, Wang X, Deb P, Sun F, Huang X, Novak M, Appleton D, Shapiro CM. Polysomnographic and symptomatological analyses of major depressive disorder patients treated with mirtazapine. Can J Psychiatry. 2006 Jan;51(1):27-34. doi: 10.1177/070674370605100106.
- Derived from this study: PubMed 19192466Shen J, Moller HJ, Wang X, Chung SA, Shapiro GK, Li X, Shapiro CM. Mirtazapine, a sedating antidepressant, and improved driving safety in patients with major depressive disorder: a prospective, randomized trial of 28 patients. J Clin Psychiatry. 2009 Mar;70(3):370-7. doi: 10.4088/jcp.08m04234. Epub 2009 Jan 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin M. Shapiro, MBBCh, PhD principal investigator
University Health Network, Toronto
Sharon A. Chung, PhD study director
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Driving Simulator Testing and Mirtazapine Treatment in people with Depression and Excessive Daytime Sleepiness, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving performance on the driving simulator. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00385437, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2006.