Duloxetine vs. Active Comparator for the Treatment of Depression

NCT00067912 | Completed Phase 4

• 2 other identifiers: 7999F1J-MC-HMCQ
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

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 (7)

• HAMD17 Response Rates: Response is defined as a greater or equal to 50% reduction in HAMD17 total score from baseline to endpoint.

• 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.

• HAMD17 Remission Rates: Remission is defined as a HAMD17 total score of less than or equal to 7 at endpoint.

• 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.

• Clinical Global Impressions of Severity (CGI-Severity) Scale to record the severity of illness at the time of assessment.

Interventions

Duloxetine Hydrochloride DRUG

Venlafaxine Extended Release DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must be at least 18 years of age
• must be diagnosed with depression
• must sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

Related Publications (1)

• Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.

  PMID: 25080392 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 29, 2003
• First Posted: September 3, 2003
• Study Start: April 1, 2003
• Study Completion: March 1, 2004
• Last Updated: May 21, 2007

Record last verified: 2007-05

Locations

CA (1)