Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder

NCT00385437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2006-10-09

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Driving Simulator Testing

DRUG

Mirtazapine Treatment

Sponsors & Collaborators

  • Organon

    collaborator INDUSTRY
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Colin M. Shapiro, MBBCh, PhD · University Health Network, Toronto

  • Sharon A. Chung, PhD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Completion
2004-06-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00385437 on ClinicalTrials.gov