Duloxetine vs. Active Comparator for the Treatment of Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

August 29, 2003

Last Updated Date

May 17, 2007

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Linear measure of global benefit-risk assessment. Benefit is defined as remission at endpoint (HMAD17 total score less than or equal to 7, a virtually symptom-free state.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00067912 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

HAMD17 Response Rates: Response is defined as a greater or equal to 50% reduction in HAMD17 total score from baseline to endpoint.
HAMD17 Time to First Response: Time to first response is defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17.
HAMD17 Remission Rates: Remission is defined as a HAMD17 total score of less than or equal to 7 at endpoint.
Hamilton Anxiety Rating Scale (HAMA) that measures the presence and severity of anxiety. The 14-item version of this scale will be used to assess the severity of anxiety and its improvement during the course of therapy.
Clinical Global Impressions of Severity (CGI-Severity) Scale to record the severity of illness at the time of assessment.
Patient's Global Impressions of Improvement (PGI Improvement) Scale is a patient-rated instrument that measures the improvement of the patient's symptoms.
HAMD17 Subscales to evaluate severity of psychic and somatic manifestations of anxiety, as well as agitation; evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation; evaluate initial, middle and late insomnia.

Original Secondary Outcome Measures ^ICMJE

HAMD17 Response Rates: Response is defined as a greater or equal to 50% reduction in HAMD17 total score from baseline to endpoint.
HAMD17 Time to First Response: Time to first response is defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17.
HAMD17 Remission Rates: Remission is defined as a HAMD17 total score of less than or equal to 7 at endpoint.
Hamilton Anxiety Rating Scale (HAMA) that measures the presence and severity of anxiety. The 14-item version of this scale will be used to assess the severity of anxiety and its improvement during the course of therapy.
Clinical Global Impressions of Severity (CGI-Severity) Scale to record the severity of illness at the time of assessment.
Patient’s Global Impressions of Improvement (PGI Improvement) Scale is a patient-rated instrument that measures the improvement of the patient’s symptoms.
HAMD17 Subscales to evaluate severity of psychic and somatic manifestations of anxiety, as well as agitation; evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation; evaluate initial, middle and late insomnia.

Descriptive Information

Brief Title ^ICMJE

Duloxetine vs. Active Comparator for the Treatment of Depression

Official Title ^ICMJE

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

Brief Summary

How duloxetine compares to a medication currently available for the treatment of depression in the treatment of patients with major depressive disorder.

The safety of duloxetine and any side effects that might be associated with it.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Duloxetine Hydrochloride
Drug: Venlafaxine Extended Release

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

480

Completion Date

March 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

must be at least 18 years of age
must be diagnosed with depression
must sign informed consent

Exclusion Criteria:

women who can become pregnant must be using birth control
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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00067912

Responsible Party

Study ID Numbers ^ICMJE

7999, F1J-MC-HMCQ

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP