Duloxetine vs. Active Comparator in the Treatment of Patients With Depression
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|ClinicalTrials.gov Identifier: NCT00071695|
Recruitment Status : Completed
First Posted : October 30, 2003
Last Update Posted : May 21, 2007
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Duloxetine Hydrochloride Drug: Venlafaxine Extended Release||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder|
|Study Start Date :||July 2003|
|Actual Study Completion Date :||May 2004|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071695
|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Easter Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.|
|La Rochelle, France|
|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|