Duloxetine Versus Duloxetine Plus Non-Drug Therapy for Depression

NCT00494377 | Completed Phase 4

• 2 other identifiers: 8601F1J-MC-HMDD
• Study Type: interventional
• Target: 940
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine if duloxetine plus non-drug intervention is more effective than duloxetine alone in patients with depression.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• To test whether duloxetine 60-120 mg daily, when combined with non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by remission rate (proportion of patients with HAMD17 score < or = 7 at endpoint)

Secondary Outcomes (18)

• To test whether duloxetine 60-120 mg daily, when combined with non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone as measured by: Mean change (baseline to endpoint) on HAMD17

• To test whether duloxetine 60-120 mg daily, when combined with non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by response rates (> or = 50% decrease from baseline to endpoint on HAMD17)

• To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by HAMD17 subscales (Core, Maier, Anxiety/Somatization, Retardation/Somatization, Sleep & General Somatic Symptoms item)

• To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by mean change from baseline to endpoint on the revised Mood and Physical symptoms of Depression scale (MAP-D)

• To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by treatment adherence as measured by the Morisky Medication Adherence Questionnaire and study drug compliance

Interventions

duloxetine DRUG

Eligibility Criteria

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

You may qualify if:

• Male or female outpatients at least 18 years of age who, in the opinion of the investigator, meet criteria for major depressive disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria.

You may not qualify if:

• Have a previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
• Serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require medication/ intervention/hospitalization during the course of the study.
• Abnormal thyroid stimulating hormone (TSH) concentration (outside the reference range of the performing laboratory). Note: Patients diagnosed with hyperthyroidism or hypothyroidism who have been treated on a stable dose of thyroid supplement for at least the past 3 months, have medically appropriate TSH concentration, and are clinically euthyroid are allowed.
• Moderate or severe hepatic impairment, including but not limited to acute liver injury (such as hepatitis), and severe (Child-Pugh Class C) cirrhosis.

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.

Vienna, Austria

Location

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 27, 2007
• First Posted: June 29, 2007
• Study Start: February 1, 2004
• Study Completion: June 1, 2005
• Last Updated: July 2, 2007

Record last verified: 2007-06

Locations

AU (1)