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

Eli Lilly and Company514 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

514

Conditions

Depressive Disorder, Major

Interventions

DuloxetineDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (34)

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

Recurrence Count

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

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

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

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.

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

Loss of Response at Any Time

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.

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

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

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).

Data from ClinicalTrials.gov

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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.

Newport Beach, California, United States

Sherman Oaks, California, United States

Baltimore, Maryland, United States

Gaithersburg, Maryland, United States

Brooklyn, New York, United States

Angoulême, France

Douai, France

Fains, France

La Rochelle, France

Lille, France

...and 24 more locations

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

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

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

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).

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

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

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

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).

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

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

Time frame: Week 86 (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 - Acute and Continuation Phases

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).

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

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

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).

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

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)

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

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.

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)

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

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.

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)

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

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

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)

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

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.

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

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

Time frame: Week 34 through Week 86 (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)

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 - 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)

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 Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)

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.

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 (Females)

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 (Males)

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

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)

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)

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

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

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)

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

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

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

Time frame: Week 0 and Week 10

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 Chloride - Acute Phase

Time frame: Week 0 and Week 10

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 Gamma-Glutamyl Transferase - Acute Phase

Time frame: Week 0 and Week 10

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

Time frame: Week 0 and Week 10

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 Platelet Count - Acute Phase

Time frame: Week 0 and Week 10

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 Total Protein - Acute Phase

Time frame: Week 0 and Week 10

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - 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)

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)

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 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 Calcium - Continuation Phase

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

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 - Continuation Phase

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

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 Leukocyte Count - Continuation Phase

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

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)

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 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 Monocytes - 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)

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 Calcium - Maintenance Phase

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

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

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

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)