Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Organon
• Treatments: Antidepressive Agents; Mirtazapine

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.