Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder

Eli Lilly and Company1 site in 1 country320 target enrollmentJuly 2003

ConditionsDepression

DrugsDuloxetine Hydrochloride Venlafaxine Extended Release

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Depression
Sponsor: Eli Lilly and Company
Enrollment: 320
Locations: 1
Primary Endpoint: The linear measure of global benefit-risk assessment. Benefit defined as remission at endpoint (HAMD 17 total score less than or equal to 7), a virtually symptom-free state.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

How duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

May 2004

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Must be at least 18 years of age
•Must be diagnosed with depression
•Must sign informed consent
•Women who can become pregnant must be using birth control

Exclusion Criteria

•Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder
•History of substance abuse or dependence in the last year
•Patients who are suicidal
•Frequent or severe allergic reactions with multiple medications

Outcomes

Primary Outcomes

The linear measure of global benefit-risk assessment. Benefit defined as remission at endpoint (HAMD 17 total score less than or equal to 7), a virtually symptom-free state.

Secondary Outcomes

HAMD17 Response Rates defined as greater than or equal to 50% reduction in HAMD17 total score from baseline to endpoint.
HAMD17 Time-to-First Response defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17.
HAMD17 Remission Rates defined as HAMD17 total score of less than or equal to 7 at endpoint.
Hamilton Anxiety Rating Scale measures the presence and severity of anxiety.
Clinical Global Impressions of Severity scale to record severity of illness at the time of assessment.
Patient's Global Impressions of Improvement scale measures improvement of the patient's symptoms.
HAMD17 Subscales evaluate severity of psychic and somatic manifestations of anxiety as well as agitation and evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation and evaluate initial, middle, and late insomnia.