A Study of Flexible or Fixed Dose LY2216684 as Adjunctive Treatment for Participants With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment
25. března 2018 aktualizováno: Eli Lilly and Company
A Randomized, Placebo-Controlled, Double-Blind Study of LY2216684 Flexible-Dose 12 mg to 18 mg Once Daily and LY2216684 Fixed-Dose 6 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment
The purpose of this study is to assess if LY2216684 (flexible dose of 12 to 18 milligrams [mg] or fixed dose of 6 mg once daily) is superior to placebo once daily in the adjunctive treatment of participants with Major Depressive Disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) during an 8-week, double-blind, acute adjunctive treatment phase.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
Following the Confirmation (CF) Phase, participants were randomized to adjunctive LY2216684 or adjunctive placebo if they had <25% improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over the past 3 weeks and a current MADRS total score ≥14.
Participants who did not meet criteria received adjunctive placebo to preserve the blind.
Typ studie
Intervenční
Zápis (Aktuální)
1480
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Rab, Chorvatsko, 51280
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Zagreb, Chorvatsko, 10090
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Helsinki, Finsko, 00100
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Joensuu, Finsko, 80100
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Kuopio, Finsko, 70110
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Tampere, Finsko, 33200
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Turku, Finsko, 20100
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Chiba, Japonsko, 270-0014
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Fukuoka, Japonsko, 810-0035
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Fukushima, Japonsko, 961-0021
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Hyogo, Japonsko, 661-0002
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Kanagawa, Japonsko, 247-0056
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Tokyo, Japonsko, 100-0006
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San Juan, Portoriko, 00918
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Bratislava, Slovensko, 85101
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Kosice, Slovensko, 04001
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Michalovce, Slovensko, SK-071 01
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Rimavska Sobota, Slovensko, 97901
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Roznava, Slovensko, 04801
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Alabama
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Birmingham, Alabama, Spojené státy, 35216
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Arizona
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Phoenix, Arizona, Spojené státy, 85032
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California
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Chino, California, Spojené státy, 91710
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Glendale, California, Spojené státy, 91204
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Imperial, California, Spojené státy, 92251
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National City, California, Spojené státy, 91950
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Sherman Oaks, California, Spojené státy, 91403
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Colorado
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Colorado Springs, Colorado, Spojené státy, 80907
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Florida
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Clearwater, Florida, Spojené státy, 33761
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Coral Gables, Florida, Spojené státy, 33145
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Fort Lauderdale, Florida, Spojené státy, 33319
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Tampa, Florida, Spojené státy, 33613
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Georgia
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Atlanta, Georgia, Spojené státy, 30308
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Illinois
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Hoffman Estates, Illinois, Spojené státy, 60169
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Indiana
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Indianapolis, Indiana, Spojené státy, 46260
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Kansas
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Prairie Village, Kansas, Spojené státy, 66206
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Wichita, Kansas, Spojené státy, 67205
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Maryland
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Baltimore, Maryland, Spojené státy, 21285
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Massachusetts
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Haverhill, Massachusetts, Spojené státy, 01830
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Weymouth, Massachusetts, Spojené státy, 02190
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Mississippi
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Flowood, Mississippi, Spojené státy, 39232
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Missouri
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O'Fallon, Missouri, Spojené státy, 63368
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New York
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Brooklyn, New York, Spojené státy, 11235
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New York, New York, Spojené státy, 10021
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Ohio
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Beachwood, Ohio, Spojené státy, 44122
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73103
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19107
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Texas
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Houston, Texas, Spojené státy, 77096
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Horovice, Česko, 268 31
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Hostivice, Česko, 25201
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Kladno, Česko, 27201
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Olomouc, Česko, 77900
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Prague, Česko, 100 00
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Strakonice, Česko, 38601
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Usti Nad Labem, Česko, 400001
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Clinical diagnosis of Major Depressive Disorder (MDD)
- Using a reliable method of birth control
- Are taking a selective serotonin reuptake inhibitor (SSRI) approved for MDD treatment within the participant's country and the SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country
- Have a partial response to SSRI treatment
- Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment
- Reliable and able to keep all scheduled appointments
Exclusion Criteria:
Presence of another primary psychiatric illness:
- Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 condition other than major depression within 1 year of screening
- Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias)
- Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder
- Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine
- Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol
- Have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, and history of urinary hesitation or retention
- Use of excluded concomitant or psychotropic medication other than SSRI
- Have initiated or discontinued hormone therapy within the previous 3 months of prior to enrollment
- History of treatment-resistant depression as shown by lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the participant has treatment-resistant depression
- Have a lifetime history of vagal nerve stimulation (VNS) transcranial magnetic stimulation (TMS), or psychosurgery
- Have received electroconvulsive therapy (ECT) in the past year
- Enrollment in a clinical study for an investigational drug
- Serious or unstable medical condition
- History of seizure disorders
- Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or any time during the study
- Participants who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 12 or 18 mg flexible dose LY2216684 + SSRI
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) Prior to entering the Adjunctive Treatment (AT) Phase, participants completed a 3-week Confirmation (CF) Phase where they received placebo (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to a 12 or 18 mg flexible dose of LY2216684. During the AT Phase, participants first received 6 mg LY2216684 QD for 3 days, followed by 12 mg QD for the next 11 days. Then, based on efficacy and tolerability, dosage could be increased to 18 mg QD over the next 6 weeks. Participants on 18 mg QD could have had their dose decreased back to 12 mg QD. Participants who completed the AT Phase or discontinued early had the option to enter the Discontinuation (DC) Phase. During the 1-week abrupt DC Phase, participants maintained their SSRI treatment. |
Ostatní jména:
Účastníci měli užívat SSRI alespoň 6 týdnů předtím a měli pokračovat ve své stabilní dávce po celou dobu studie
Ostatní jména:
|
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Experimentální: 6 mg fixed dose LY2216684 + SSRI
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI Prior to entering the AT Phase, participants completed a 3-week CF Phase where they received placebo (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to 6 mg fixed dose of LY2216684. During the AT Phase, participants received a 6 mg fixed dose of LY2216684 adjunctive to their SSRI for 8 weeks. Participants who completed the AT Phase or discontinued early had the option to enter the DC Phase. During the 1-week abrupt DC Phase, participants maintained their SSRI treatment. |
Ostatní jména:
Účastníci měli užívat SSRI alespoň 6 týdnů předtím a měli pokračovat ve své stabilní dávce po celou dobu studie
Ostatní jména:
|
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Komparátor placeba: Placebo + SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI Prior to entering the AT Phase, participants completed a 3-week CF Phase where they received placebo (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to placebo. During the AT Phase, participants received placebo (administered orally, QD) adjunctive to their SSRI for 8 weeks. Participants who completed the AT Phase or discontinued early had the option to enter the DC Phase. During the 1-week abrupt DC Phase, participants maintained their SSRI treatment. |
Účastníci měli užívat SSRI alespoň 6 týdnů předtím a měli pokračovat ve své stabilní dávce po celou dobu studie
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Časové okno: Randomization, 8 weeks
|
The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts).
Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
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Randomization, 8 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Změna z Randomizace na 8. týden v EuroQol Questionnaire-5 Dimension (EQ-5D)
Časové okno: Randomizace, 8 týdnů
|
Vizuální analogová škála EQ-5D je generický, vícerozměrný nástroj zaměřený na kvalitu života související se zdravím.
Celkové skóre zdravotního stavu je samo-vykazováno pomocí vizuální analogové škály, označené na stupnici od 0 do 100, přičemž 0 představuje nejhorší představitelný zdravotní stav a 100 představuje nejlepší představitelný zdravotní stav.
Střední hodnoty nejmenších čtverců (LS) byly vypočteny pomocí smíšených modelových opakovaných měření (MMRM) s úpravou pro léčbu, zkoušejícího, návštěvu, základní skóre, léčbu po návštěvě a základní skóre po návštěvě.
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Randomizace, 8 týdnů
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Změna krevního tlaku z randomizace na týden 8
Časové okno: Randomizace, 8 týdnů
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Měření krevního tlaku bylo sbíráno, když účastník seděl.
Tři měření krevního tlaku vsedě odebraná v přibližně 1minutových intervalech při každé návštěvě byla zprůměrována a použita jako hodnota pro návštěvu.
Střední hodnoty nejmenších čtverců (LS) byly vypočteny pomocí smíšených modelových opakovaných měření (MMRM) s úpravou pro léčbu, zkoušejícího, návštěvu, výchozí hodnotu, léčbu po návštěvě a výchozí hodnotu po návštěvě.
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Randomizace, 8 týdnů
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Změna z Randomizace na týden 8 v tepové frekvenci
Časové okno: Randomizace, 8 týdnů
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Měření pulsu bylo sbíráno, když účastník seděl.
Střední hodnoty nejmenších čtverců (LS) byly vypočteny pomocí smíšených modelových opakovaných měření (MMRM) s úpravou pro léčbu, zkoušejícího, návštěvu, výchozí hodnotu, léčbu po návštěvě a výchozí hodnotu po návštěvě.
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Randomizace, 8 týdnů
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Změna z randomizace na týden 8 v Montgomery-Asbergově stupnici hodnocení deprese (MADRS) jednotlivé položky
Časové okno: Randomizace, 8 týdnů
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MADRS je hodnotící stupnice závažnosti symptomů depresivní nálady.
MADRS měl 10-položkový kontrolní seznam (smutek [zdánlivý], smutek [uváděný], vnitřní napětí, snížený spánek, snížená chuť k jídlu, potíže s koncentrací, malátnost, neschopnost cítit, pesimistické myšlenky a sebevražedné myšlenky).
Položky byly hodnoceny na stupnici od 0 do 6, pro celkový rozsah skóre od 0 (nízká závažnost symptomů deprese) do 60 (vysoká závažnost symptomů deprese).
Střední hodnoty nejmenších čtverců (LS) byly vypočteny pomocí smíšených modelových opakovaných měření (MMRM) s úpravou pro léčbu, zkoušejícího, návštěvu, výchozí bodové skóre, ošetření po návštěvě a výchozí bodové skóre po návštěvě.
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Randomizace, 8 týdnů
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Change From Randomization to Week 8 in the Sheehan Disability Scale (SDS) Global Functional Impairment Score
Časové okno: Randomization, 8 weeks
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The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3).
Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption.
The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score).
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in the Fatigue Associated With Depression (FAsD) Impact Subscale Score
Časové okno: Randomization, 8 weeks
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The FAsD is a participant-rated scale with a total of 13 items.
Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always).
Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much).
The impact subscale score was derived by taking the mean of Items 7 through 13 (applicable items only).
Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school.
The FAsD impact subscale score ranges from 1 to 5. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.
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Randomization, 8 weeks
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Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 up to Week 8
Časové okno: Randomization up to 8 weeks
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A MADRS total score of less than or equal to 10 was defined as remission criteria.
The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts).
Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Percentage of participants was calculated by dividing the number of participants who meet criteria for remission by the total number of participants analyzed, multiplied by 100%.
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Randomization up to 8 weeks
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Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement
Časové okno: Randomization up to 8 weeks
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A MADRS total score of less than or equal to 10 for at least 2 consecutive measurements, including the participant's last measurement was defined as remission criteria at last 2 consecutive visits.
The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts).
Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Percentage of participants was calculated by dividing the number of participants who meet criteria for remission at last 2 consecutive visits by the total number of participants analyzed, multiplied by 100%.
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Randomization up to 8 weeks
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Change From Randomization to Week 8 in the Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score
Časové okno: Randomization, 8 weeks
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The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression.
Each item was rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety and depression subscale.
Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8 to 10 represent 'borderline' and scores of 0 to 7 represent 'normal'.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.
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Randomization, 8 weeks
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Percentage of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization up to Week 8
Časové okno: Randomization up to 8 weeks
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A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the MADRS total score was defined as response criteria.
The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts).
Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Percentage of participants was calculated by dividing the number of participants meeting response criteria at last visit by the total number of participants analyzed, multiplied by 100%.
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Randomization up to 8 weeks
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Change From Randomization to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
Časové okno: Randomization, 8 weeks
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The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression.
Each item was rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety and depression subscale.
Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8 to 10 represent 'borderline' and scores of 0 to 7 represent 'normal'.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)
Časové okno: Randomization, 8 weeks
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CGI-S measures severity of depression at the time of assessment compared with the start of treatment.
Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit
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Randomization, 8 weeks
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Change From Randomization to Week 8 in The Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score
Časové okno: Randomization, 8 weeks
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The FAsD is a participant-rated scale with a total of 13 items.
Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always).
Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much).
The experience subscale score was derived by taking the mean of Items 1 through 6, and the average score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant).
Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items
Časové okno: Randomization, 8 weeks
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The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score).
Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit, and baseline item score-by-visit.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Časové okno: Randomization, 8 weeks
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The Q-LES-Q-SF is a self-administered 16 item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point Likert scale (1=very poor and 5=very good).
The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70.
The raw scores are converted to and expressed as the percentage of the maximum possible score.
Higher scores indicate higher levels of enjoyment/satisfaction.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
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Randomization, 8 weeks
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Percentage of Participants With Treatment-emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Časové okno: Randomization through 8 weeks
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The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors.
Suicidal ideation was defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation.
Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present at baseline.
Percentage of participants was calculated by dividing the number of participants with suicide-related TE events by the total number of participants analyzed, multiplied by 100%.
A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Event module.
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Randomization through 8 weeks
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Change From Randomization to Week 8 in the Arizona Sexual Experiences (ASEX) Scale
Časové okno: Randomization, 8 weeks
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The ASEX scale was used to assess sexual functioning in both males and females.
The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) of the 5 items of the ASEX scale.
Total scores ranged from 5 to 30, with higher scores indicating greater sexual dysfunction.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
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Randomization, 8 weeks
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Change From Randomization to Week 8 in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
Časové okno: Randomization, 8 weeks
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The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being.
It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity.
Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent).
Total scores ranged from 7 to 42.
Higher scores indicate greater disease severity.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
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Randomization, 8 weeks
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Pharmacokinetics: Plasma Concentrations of LY2216684
Časové okno: Pre-randomization, 1 week, 4 weeks, and 8 weeks
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A validated bioanalytical assay was used to determine plasma LY2216684 concentrations.
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Pre-randomization, 1 week, 4 weeks, and 8 weeks
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Stauffer VL, Liu P, Goldberger C, Marangell LB, Nelson C, Gorwood P, Fava M. Is the Noradrenergic Symptom Cluster a Valid Construct in Adjunctive Treatment of Major Depressive Disorder? J Clin Psychiatry. 2017 Mar;78(3):317-323. doi: 10.4088/JCP.15m09972.
- Ball SG, Ferguson MB, Martinez JM, Pangallo BA, Nery ES, Dellva MA, Sparks J, Zhang Q, Liu P, Bangs M, Goldberger C. Efficacy outcomes from 3 clinical trials of edivoxetine as adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment. J Clin Psychiatry. 2016 May;77(5):635-42. doi: 10.4088/JCP.14m09619.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2011
Primární dokončení (Aktuální)
1. srpna 2013
Dokončení studie (Aktuální)
1. srpna 2013
Termíny zápisu do studia
První předloženo
20. srpna 2010
První předloženo, které splnilo kritéria kontroly kvality
23. srpna 2010
První zveřejněno (Odhad)
24. srpna 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. dubna 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. března 2018
Naposledy ověřeno
1. března 2018
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Symptomy chování
- Duševní poruchy
- Poruchy nálady
- Deprese
- Deprese
- Depresivní porucha, major
- Fyziologické účinky léků
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Inhibitory vychytávání neurotransmiterů
- Membránové transportní modulátory
- Serotoninové látky
- Agonisté serotoninových receptorů
- Serotonin
- Inhibitory vychytávání serotoninu
Další identifikační čísla studie
- 12182
- H9P-MC-LNBQ (Jiný identifikátor: Eli Lilly and Company)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Velká depresivní porucha (MDD)
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Bangabandhu Sheikh Mujib Medical University, Dhaka...Neznámý
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Changping LaboratoryNábor
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Mclean HospitalDokončenoVelká depresivní porucha | MDD | CitalopramSpojené státy