A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression (TRY FIRST)
12. maj 2010 opdateret af: Eli Lilly and Company
TRY FIRST: A 12-Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode
The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
750
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Carson, California, Forenede Stater, 90746
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Irvine, California, Forenede Stater, 92618
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San Diego, California, Forenede Stater, 92108
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Sherman Oaks, California, Forenede Stater, 91403
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Torrance, California, Forenede Stater, 90502
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Colorado
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Pueblo, Colorado, Forenede Stater, 81008
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Florida
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Clearwater, Florida, Forenede Stater, 33765
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Coral Springs, Florida, Forenede Stater, 33065
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Deerfield Beach, Florida, Forenede Stater, 33064
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Fort Myers, Florida, Forenede Stater, 33912
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Gainesville, Florida, Forenede Stater, 32607
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Hialeah, Florida, Forenede Stater, 33016
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Melbourne, Florida, Forenede Stater, 32901
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Miami, Florida, Forenede Stater, 33173
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Winter Park, Florida, Forenede Stater, 32789
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Georgia
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Atlanta, Georgia, Forenede Stater, 30338
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Illinois
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Joliet, Illinois, Forenede Stater, 60435
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Oak Brook, Illinois, Forenede Stater, 60523
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Park Ridge, Illinois, Forenede Stater, 60068
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Indiana
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Greenwood, Indiana, Forenede Stater, 46143
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Terre Haute, Indiana, Forenede Stater, 47802
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Kansas
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Prairie Village, Kansas, Forenede Stater, 66206
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Wichita, Kansas, Forenede Stater, 67203
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Maryland
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Gaithersburg, Maryland, Forenede Stater, 20877
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Glen Burnie, Maryland, Forenede Stater, 21061
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Rockville, Maryland, Forenede Stater, 20852
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Massachusetts
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Fall River, Massachusetts, Forenede Stater, 02721
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Missouri
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St Louis, Missouri, Forenede Stater, 63141
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New Jersey
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Clementon, New Jersey, Forenede Stater, 08021
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Princeton, New Jersey, Forenede Stater, 08540
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New York
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Brooklyn, New York, Forenede Stater, 11223
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Fresh Meadows, New York, Forenede Stater, 11366
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Mount Kisco, New York, Forenede Stater, 10549
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Rochester, New York, Forenede Stater, 14618
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Staten Island, New York, Forenede Stater, 10312
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Concord, North Carolina, Forenede Stater, 28025
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Durham, North Carolina, Forenede Stater, 27707
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Ohio
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Beachwood, Ohio, Forenede Stater, 44122
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Dayton, Ohio, Forenede Stater, 45432
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Kettering, Ohio, Forenede Stater, 45429
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73119
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Oregon
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Eugene, Oregon, Forenede Stater, 97404
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Pennsylvania
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Havertown, Pennsylvania, Forenede Stater, 19083
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Media, Pennsylvania, Forenede Stater, 19063
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Newtown, Pennsylvania, Forenede Stater, 18940
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Philadelphia, Pennsylvania, Forenede Stater, 19139
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Rhode Island
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Lincoln, Rhode Island, Forenede Stater, 02865
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29201
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
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Texas
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Austin, Texas, Forenede Stater, 78756
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Dallas, Texas, Forenede Stater, 75231
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Friendswood, Texas, Forenede Stater, 77546
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Houston, Texas, Forenede Stater, 77074
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Lake Jackson, Texas, Forenede Stater, 77566
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San Antonio, Texas, Forenede Stater, 78229
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Wichita Falls, Texas, Forenede Stater, 76309
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Vermont
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Woodstock, Vermont, Forenede Stater, 05091
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22903
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Herndon, Virginia, Forenede Stater, 20170
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Washington
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Bellevue, Washington, Forenede Stater, 98004
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Wisconsin
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Brown Deer, Wisconsin, Forenede Stater, 53223
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion criteria:
- At least 18 years of age
- Have major depression and are currently in a severe depressive episode
- Have a degree of understanding such that patient can communicate with the investigator and study staff
- All females must test negative for pregnancy
- Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug
Exclusion criteria:
- Have not responded to duloxetine for depression in the past
- Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD)
- Are at significant risk for suicide
- Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
- Have a serious, unstable medical condition
- Have a current or recent history of substance abuse or dependence
- Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year
- Have started psychotherapy within 6 weeks prior to study entry
- Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: paroxetin
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20-50 mgs orally daily for 12 weeks
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Aktiv komparator: fluoxetin
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20-80 mgs orally daily for 12 weeks
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Eksperimentel: duloxetine
study drug
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30-120 milligrams (mgs) orally daily for 12 weeks
Andre navne:
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Aktiv komparator: citalopram
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20-40 mgs orally daily for 12 weeks
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Aktiv komparator: sertraline
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50-200 mgs orally daily for 12 weeks
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]
Tidsramme: 12 weeks
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Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score [TS]</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant.
Primary analysis contrasted remission probability at week 12 endpoint between treatment groups.
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12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)
Tidsramme: Baseline, 12 weeks
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The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation.
Scores range from 0 (none) to 27 (very severe).
The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression.
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Baseline, 12 weeks
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Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]
Tidsramme: 12 weeks
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Visitwise percentages of participants meeting remission criteria HAMD-17 total score [TS] </=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS.
Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy.
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12 weeks
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Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]
Tidsramme: Baseline, 12-Weeks
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Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR.
The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.
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Baseline, 12-Weeks
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Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]
Tidsramme: Baseline, 12-Weeks
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Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS.
Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.
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Baseline, 12-Weeks
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Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)
Tidsramme: Baseline, 12 Weeks
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The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed).
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Baseline, 12 Weeks
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Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)
Tidsramme: Baseline, 12 Weeks
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HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety.
Total subscale scores range from 0 (normal) to 18 (severe).
Mean change from baseline to endpoint.
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Baseline, 12 Weeks
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Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)
Tidsramme: Baseline, 12 weeks
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HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the "core" symptoms of depression.
Total subscale scores range from 0 (normal) to 24 (severe).
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Baseline, 12 weeks
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Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)
Tidsramme: Baseline, 12 Weeks
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HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD).
Total subscale scores range from 0 (normal) to 22 (severe).
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Baseline, 12 Weeks
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Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)
Tidsramme: Baseline, 12 Weeks
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The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation.
Total subscale scores range from 0 (normal) to 14 (severe).
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Baseline, 12 Weeks
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Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)
Tidsramme: Baseline, 12 Weeks
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The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia.
Total subscale scores range from 0 (no difficulty) to 6 (difficulty).
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Baseline, 12 Weeks
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Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure)
Tidsramme: Baseline, 12 Weeks
|
The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline.
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Baseline, 12 Weeks
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Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)
Tidsramme: Baseline, 12 weeks
|
The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes).
The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint.
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Baseline, 12 weeks
|
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Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)
Tidsramme: Baseline, 12 weeks
|
The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning.
The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint.
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Baseline, 12 weeks
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Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)
Tidsramme: Baseline, 12 Weeks
|
The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule.
Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life.
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Baseline, 12 Weeks
|
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Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)
Tidsramme: Baseline, 12 Weeks
|
The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities.
Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities.
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Baseline, 12 Weeks
|
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Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)
Tidsramme: Baseline, 12 Weeks
|
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life.
Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.
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Baseline, 12 Weeks
|
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Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint
Tidsramme: Baseline, 12 Weeks
|
Mean change from baseline to endpoint in systolic blood pressure
|
Baseline, 12 Weeks
|
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Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint
Tidsramme: Baseline, 12 Weeks
|
Mean change from baseline to endpoint in diastolic blood pressure
|
Baseline, 12 Weeks
|
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Change From Baseline in Pulse Rate at Week-12 Endpoint
Tidsramme: Baseline, 12 Weeks
|
Mean change from baseline to endpoint in pulse rate
|
Baseline, 12 Weeks
|
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Change From Baseline in Weight at Week-12 Endpoint
Tidsramme: Baseline, 12 Weeks
|
Mean change from baseline to endpoint in weight
|
Baseline, 12 Weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint
Tidsramme: Baseline, 12 Weeks
|
WP score was calculated by taking midpoint of annual before-tax income reported on HPQ.
A multiplier of 1.25 produced estimated direct & indirect (i.e.
benefits) income.
Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days.
Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours.
Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP.
|
Baseline, 12 Weeks
|
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Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint
Tidsramme: Baseline, 12 weeks
|
Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income.
Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs.
Scale ranges from 0 to 100% of work days in past 30 days.
Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value ([100-absenteeism] × [100-presenteeism]).
Mean change baseline to endpoint.
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Baseline, 12 weeks
|
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Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint
Tidsramme: Baseline, 12 Weeks
|
Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income.
Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs.
Defined on a 0-100 scale for the percentage of work days the respondent missed in the past 30 days.
Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days.
Mean change baseline to endpoint is reported.
|
Baseline, 12 Weeks
|
|
Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint
Tidsramme: Baseline, 12 Weeks
|
Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income).
Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0-100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker.
Absolute presenteeism: difference between "score for self" and "score for average worker in same job".
Mean change baseline to endpoint is reported.
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Baseline, 12 Weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT-5 hours, EST), Eli Lilly and Company
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.
- Martinez JM, Katon W, Greist JH, Kroenke K, Thase ME, Meyers AL, Edwards SE, Marangell LB, Shoemaker S, Swindle R. A pragmatic 12-week, randomized trial of duloxetine versus generic selective serotonin-reuptake inhibitors in the treatment of adult outpatients in a moderate-to-severe depressive episode. Int Clin Psychopharmacol. 2012 Jan;27(1):17-26. doi: 10.1097/YIC.0b013e32834ce11b.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2008
Primær færdiggørelse (Faktiske)
1. februar 2009
Studieafslutning (Faktiske)
1. marts 2009
Datoer for studieregistrering
Først indsendt
23. april 2008
Først indsendt, der opfyldte QC-kriterier
24. april 2008
Først opslået (Skøn)
25. april 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. juni 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. maj 2010
Sidst verificeret
1. maj 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Adfærdsmæssige symptomer
- Psykiske lidelser
- Stemningsforstyrrelser
- Depression
- Depressiv lidelse
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Psykotropiske stoffer
- Serotoninoptagelseshæmmere
- Neurotransmitter optagelseshæmmere
- Membrantransportmodulatorer
- Serotoninmidler
- Antidepressive midler
- Dopaminmidler
- Cytokrom P-450 enzymhæmmere
- Antidepressive midler, anden generation
- Serotonin- og Noradrenalin-genoptagelseshæmmere
- Cytokrom P-450 CYP2D6-hæmmere
- Sertralin
- Duloxetinhydrochlorid
- Citalopram
- Paroxetin
- Fluoxetin
Andre undersøgelses-id-numre
- 11715 (DAIDS ES)
- F1J-US-HMFT (Anden identifikator: Eli Lilly and Company)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .