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Duloxetine Versus Duloxetine Plus Non-Drug Therapy for Depression
This study has been completed.
Study NCT00494377   Information provided by Eli Lilly and Company
First Received: June 27, 2007   Last Updated: June 28, 2007   History of Changes

June 27, 2007
June 28, 2007
February 2004
 
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)
Same as current
Complete list of historical versions of study NCT00494377 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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
  • 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)
  • 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)
  • 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
  • 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
  • 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)
  • To evaluate the incidence of adverse events during Study Period III (optional taper period) as measured by spontaneously reported adverse events
  • 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
Same as current
 
Duloxetine Versus Duloxetine Plus Non-Drug Therapy for Depression
Duloxetine Versus Duloxetine Plus Non-Pharmacological Intervention in the Treatment of Depression

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.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Depression
Drug: duloxetine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
940
June 2005
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00494377
 
8601, F1J-MC-HMDD
Eli Lilly and Company
 
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
Eli Lilly and Company
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP