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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00105989
• Date of registration: 18/03/2005
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
• Scientific title: Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
• Date of first enrolment: March 2005
• Target sample size: 514
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00105989
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

France, Germany, Italy, Russian Federation, Sweden, United States

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Depressive Disorder, Major

Intervention(s)

Drug: placebo

Drug: Duloxetine

Primary Outcome(s)

Percentage of Participants With Depressive Recurrence After Time (t) in Days [Time Frame: Every Visit from Week 34 up to Week 86 (Maintenance Phase)]

Secondary Outcome(s)

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)]

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)]

Recurrence Count [Time Frame: Every Visit from Week 35 up to Week 86 (Maintenance Phase)]

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)]

Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase [Time Frame: Week 34 through Week 86 (Maintenance Phase)]

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)]

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)]

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)]

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)]

Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase [Time Frame: Week 86 (Maintenance Phase)]

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)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase [Time Frame: Week 0 and Week 10]

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)]

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)]

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)]

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)]

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)]

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)]

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)]

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)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase [Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)]

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)]

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)]

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)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase [Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase [Time Frame: Week 0 and Week 10]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase [Time Frame: Week 0 and Week 10]

Loss of Response at Any Time [Time Frame: Every Visit from Week 35 up to Week 86 (Maintenance Phase)]

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)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase [Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)]

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)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase [Time Frame: Week 0 and Week 10]

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)]

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)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase [Time Frame: Week 0 and Week 10]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase [Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)]

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)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase [Time Frame: Week 0 and Week 10]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase [Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)]

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)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase [Time Frame: Week 0 and Week 10]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase [Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase [Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase [Time Frame: Week 0 and Week 10]

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)]

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)]

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)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase [Time Frame: Week 0 and Week 10]

Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase [Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)]

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)]

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)]

Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase [Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)]

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)]

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)]

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)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase [Time Frame: Week 0 and Week 10]

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)]

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)]

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase [Time Frame: Week 0 and Week 10]

Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase [Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)]

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)]

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)]

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)]

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)]

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)]

Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase [Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)]

Secondary ID(s)

F1J-MC-HMDI

8606

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boehringer Ingelheim

Results

• Results available: Yes
• Date Posted: 17/07/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00105989