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Duloxetine vs. Active Comparator for the Treatment of Depression

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00067912
First received: August 29, 2003
Last updated: May 17, 2007
Last verified: May 2007
History of Changes

August 29, 2003
May 17, 2007
April 2003
Not Provided
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.
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Complete list of historical versions of study NCT00067912 on ClinicalTrials.gov Archive Site
  • 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.
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Duloxetine vs. Active Comparator for the Treatment of Depression
Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Depression
  • Drug: Duloxetine Hydrochloride
  • Drug: Venlafaxine Extended Release
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
March 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00067912
7999, F1J-MC-HMCQ
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Not Provided
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
May 2007

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