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OpenTrials
Completed

NCT Number: NCT00105989

Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Angoulême, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient must be at least 18 years old.
  • Patient must be diagnosed with depression and have had previous episodes of depression.
  • Patient must sign informed consent.

Exclusion criteria

  • Female and pregnant or breastfeeding.
  • History of bipolar disorder, schizophrenia, or other psychotic disorders.
  • Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization.
  • Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study.
  • Have taken an antidepressant called fluoxetine within 30 days of the start of the study.

Treatment and study plan

Duloxetine

Drug

Other names: LY248686, Cymbalta

Placebo

Drug

Primary outcomes

  1. Percentage of Participants With Depressive Recurrence After Time (t) in Days

    Time frame: Every Visit from Week 34 up to Week 86 (Maintenance Phase)

    Recurrence: Clinical Global Impression-Severity (CGI-S) score >=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.

Secondary outcomes

  1. Recurrence Count

    Time frame: Every Visit from Week 35 up to Week 86 (Maintenance Phase)

    Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase.

  2. Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days

    Time frame: Every Visit from Week 34 up to Week 86 (Maintenance Phase)

    Worsening occurs if patient had a >=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score >=3 at any time during the double-blind maintenance therapy phase.

  3. Loss of Response at Any Time

    Time frame: Every Visit from Week 35 up to Week 86 (Maintenance Phase)

    Loss of response was defined as a HAMD-17 total score >9 and a CGI-Severity score >2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not.

  4. Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

    The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).

  5. Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

    The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).

  6. Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

    Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

  7. Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

    Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.

  8. Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases

    Time frame: Week 10 (Acute) and Week 34 (Continuation)

    A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

  9. Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase

    Time frame: Week 86 (Maintenance Phase)

    A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

  10. Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

    Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood Item (0-4).

  11. Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

    Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood item (0-4).

  12. Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

    VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).

  13. Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

    VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).

  14. Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

    The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.

  15. Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

    The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.

  16. Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

    The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.

  17. Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

    The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.

  18. Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

    Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.

  19. Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

    Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.

  20. Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases

    Time frame: Week 0 through Week10 (Acute) through Week 34 (Continuation)

    Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.

  21. Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase

    Time frame: Week 34 through Week 86 (Maintenance Phase)

    Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.

  22. Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

    Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.

  23. Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

    Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.

  24. Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

    Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.

  25. Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

    Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.

  26. Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

    A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.

  27. Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

    A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.

  28. Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

    A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.

  29. Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

    A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.

  30. Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

  31. Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

  32. Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

  33. Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

  34. Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases

    Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)

  35. Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

  36. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase

    Time frame: Week 0 and Week 10

  37. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase

    Time frame: Week 0 and Week 10

  38. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase

    Time frame: Week 0 and Week 10

  39. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase

    Time frame: Week 0 and Week 10

  40. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase

    Time frame: Week 0 and Week 10

  41. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase

    Time frame: Week 0 and Week 10

  42. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase

    Time frame: Week 0 and Week 10

  43. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase

    Time frame: Week 0 and Week 10

  44. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase

    Time frame: Week 0 and Week 10

  45. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase

    Time frame: Week 0 and Week 10

  46. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase

    Time frame: Week 0 and Week 10

  47. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  48. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  49. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  50. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  51. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  52. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  53. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  54. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  55. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  56. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  57. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  58. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  59. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  60. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  61. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase

    Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)

  62. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

  63. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

  64. Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase

    Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)

  65. Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase

    Time frame: Every Visit from Week 0 up to Week 10 (Acute)

  66. Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase

    Time frame: Every Visit from Week 10 up to Week 34 (Continuation)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 21, 2005
Registry last updated
Jul 28, 2009

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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