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Duloxetine vs. Active Comparator for the Treatment of Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00067912
Recruitment Status : Completed
First Posted : September 3, 2003
Last Update Posted : May 21, 2007
Sponsor:
Information provided by:

Study Description
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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 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 : April 2003
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. HAMD17 Response Rates: Response is defined as a greater or equal to 50% reduction in HAMD17 total score from baseline to endpoint.
  2. 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.
  3. HAMD17 Remission Rates: Remission is defined as a HAMD17 total score of less than or equal to 7 at endpoint.
  4. 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.
  5. Clinical Global Impressions of Severity (CGI-Severity) Scale to record the severity of illness at the time of assessment.
  6. Patient's Global Impressions of Improvement (PGI Improvement) Scale is a patient-rated instrument that measures the improvement of the patient's symptoms.
  7. 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.

Eligibility Criteria

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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

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
Contacts and Locations

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): NCT00067912


Locations
Canada, Alberta
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 to 5 PM eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Calgary, Alberta, Canada
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00067912     History of Changes
Other Study ID Numbers: 7999
F1J-MC-HMCQ
First Posted: September 3, 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