Depressive Disorder, MajorPhase 3NCT00105989
Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
A Phase 3 study testing Duloxetine in people with Depressive Disorder, Major, run by Eli Lilly and Company at 34 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 514 participants
- Where
- 34 sitesin 6 countries
- Study dates
- Mar 2005to Jan 2008
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 6 countries.
34 sites in 6 countries
France8 sites
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
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Douai
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Fains
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La Rochelle
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Lille
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Nîmes
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Roubaix
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Strasbourg
Germany7 sites
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Berlin
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Ellwangen
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Hamburg
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Hildesheim
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Leipzig
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München
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Würzburg
Italy6 sites
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Catania
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Ferrara
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Florence
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Parma
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Roma
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Torino
United States5 sites
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Baltimore, Maryland
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Brooklyn, New York
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Gaithersburg, Maryland
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Newport Beach, California
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Sherman Oaks, California
Sweden5 sites
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Halmstad
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Lund
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Malmö
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Stockholm
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Sundsvall
Russia3 sites
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Moscow
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Saint Petersburg
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Village Nikolskoe
About this study
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.
- Conditions
- Depressive Disorder, Major
- Being tested
- Duloxetine, placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called LY248686, Cymbalta
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks Receives: Drug: Duloxetine |
| B | Placebo comparator | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every Visit from Week 34 up to Week 86 (Maintenance Phase)
Secondary outcomes (66)
Recurrence Count
Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
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
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).
Measured: 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).
Measured: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - 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).
Measured: 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.
Measured: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - 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.
Measured: 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.
Measured: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: Week 0 through Week10 (Acute) through Week 34 (Continuation)
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Measured: 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)
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.
Measured: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (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.
Measured: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)
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.
Measured: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases
Measured: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase
Measured: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases
Measured: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase
Measured: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases
Measured: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase
Measured: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase
Measured: Week 0 and Week 10
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase
Measured: Week 0 and Week 10
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase
Measured: Week 0 and Week 10
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase
Measured: Week 0 and Week 10
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase
Measured: Week 0 and Week 10
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase
Measured: Week 0 and Week 10
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase
Measured: Week 0 and Week 10
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase
Measured: Week 0 and Week 10
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase
Measured: Week 0 and Week 10
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase
Measured: Week 0 and Week 10
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase
Measured: Week 0 and Week 10
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase
Measured: 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
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase
Measured: 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
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase
Measured: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase
Measured: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase
Measured: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase
Measured: 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
Measured: 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
Measured: Every Visit from Week 10 up to Week 34 (Continuation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2005 (estimated)
- Study startMar 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105989
- Sponsor's protocol ID
- 8606
- Other IDs
- F1J-MC-HMDI
- Status last verified
- Jul 2009
- First submitted
- 18 Mar 2005
- Last updated
- 28 Jul 2009
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Perahia DG, Maina G, Thase ME, Spann ME, Wang F, Walker DJ, Detke MJ. Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 May;70(5):706-16. doi: 10.4088/jcp.08m04756.
PubMed 19552867