Duloxetine Versus Duloxetine Plus Non-Drug Therapy for Depression

Depression Clinical Trial

Official title:

Duloxetine Versus Duloxetine Plus Non-Pharmacological Intervention in the Treatment of Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494377
• Other study ID #: 8601
• Secondary ID: F1J-MC-HMDD
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2007
• Last updated: June 28, 2007
• Start date: February 2004
• Est. completion date: June 2005

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 940
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• duloxetine

Locations

Country	Name	City	State
Austria	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.	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by Clinical Global Impression of Severity (CGI - Severity) Rating Scale
Secondary	To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by Patient Global Impression of Improvement (PGI - Improvement) Rating Scale
Secondary	To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by patient satisfaction with medication and treatment overall as measured by a Visual Analogue Scale (VAS)
Secondary	To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by attitudes to taking medicines as measured by the Beliefs about Medicines Questionnaire (BMQ)
Secondary	To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by Quality of Life and Health Outcome measure: EuroQol Questionnaire (EQ-5D)
Secondary	To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by Quality of Life and Health Outcome measure: Symptom Questionnaire
Secondary	To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by Quality of Life and Health Outcome measure: Somatic Subscale (SQ-SS)
Secondary	To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by Quality of Life and Health Outcome measure: 36-item Short-Form Health Survey (SF-36)
Secondary	To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by Quality of Life and Health Outcome measure: Resource Use and Hospitalization Module
Secondary	To test if duloxetine 60-120 mg daily + non-pharmacological intervention, is superior to duloxetine 60-120 mg daily alone, measured by painful physical symptoms of depression as measured by the VAS for Pain
Secondary	To evaluate safety and tolerability of duloxetine 60-120 mg daily when combined with non-pharmacological intervention and duloxetine 60-120 mg daily alone, as measured by spontaneously reported treatment-emergent adverse events (TEAEs)
Secondary	To evaluate the incidence of adverse events during Study Period III (optional taper period) as measured by spontaneously reported adverse events
Secondary	To validate a revised version of the MAP-D (a novel scale for the measurement of emotional and physical symptoms of depression) in European outpatients with depression

External Links

•   Lilly Clinical Trial Registry