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OpenTrials
Completed

NCT Number: NCT00067912

Duloxetine vs. Active Comparator for the Treatment of Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

duloxetine hydrochloride

Drug

Venlafaxine Extended Release

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder

Important dates

Study start
2003
Study completion
2004
First posted
Sep 3, 2003
Registry last updated
May 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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