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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
Sponsor:
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Depression Drug: Duloxetine Hydrochloride Drug: Venlafaxine Extended Release Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. HAMD17 Response Rates defined as greater than or equal to 50% reduction in HAMD17 total score from baseline to endpoint.
  2. 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.
  3. HAMD17 Remission Rates defined as HAMD17 total score of less than or equal to 7 at endpoint.
  4. Hamilton Anxiety Rating Scale measures the presence and severity of anxiety.
  5. Clinical Global Impressions of Severity scale to record severity of illness at the time of assessment.
  6. Patient's Global Impressions of Improvement scale measures improvement of the patient's symptoms.
  7. 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00071695     History of Changes
Other Study ID Numbers: 6090
F1J-MC-HMBU
First Posted: October 30, 2003    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents
Antidepressive Agents, Second-Generation