Status:
COMPLETED
Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Organon
Conditions:
Depression
Excessive Daytime Sleepiness
Eligibility:
All Genders
25-50 years
Phase:
PHASE2
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 b...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2004
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00385437
Start Date
April 1 2003
End Date
June 1 2004
Last Update
October 9 2006
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5T 2S8