Duloxetine vs. Active Comparator in the Treatment of Patients With Depression
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00071695
First received: October 29, 2003
Last updated: May 17, 2007
Last verified: May 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
How duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Duloxetine Hydrochloride Drug: Venlafaxine Extended Release |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder |
Resource links provided by NLM:
Drug Information available for:
Venlafaxine
Venlafaxine hydrochloride
Duloxetine
Duloxetine hydrochloride
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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.
| Estimated Enrollment: | 320 |
| Study Start Date: | July 2003 |
| Study Completion Date: | May 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00071695
Locations
| France | |
| 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 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00071695 History of Changes |
| Other Study ID Numbers: | 6090, F1J-MC-HMBU |
| Study First Received: | October 29, 2003 |
| Last Updated: | May 17, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Venlafaxine Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents |
ClinicalTrials.gov processed this record on May 19, 2013