Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder (NCT00385437) | Clinical Trial Compass
CompletedPhase 2
Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder
Canada16 participantsStarted 2003-04
Plain-language 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.
Who can participate
Age range
25 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.