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Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

4 listopada 2014 zaktualizowane przez: Takeda

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder

The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with major depressive disorder.

The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive disorder.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S and Takeda for the treatment of major depressive disorder and general anxiety disorder. Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity in the general population. The estimated lifetime prevalence of major depression in the adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in men. The hallmark of the disease is a depressed mood, with additional symptoms including sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss, concentration difficulties and delusional ideas. In addition to direct ill effects, MDD causes suicide or job loss and exerts indirect influence on social economy. This study will assess the efficacy and the safety of Lu AA21004. This study consists of a 1-week screening period, an 8-week double-blind treatment period, 4-week safety follow-up.The duration of the study is 13 weeks in total. Blood samples will be collected from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week double-blind treatment period. Subjects who complete the 8-week double-blind treatment period can successively enter a long-term extension study (Lu AA21004/OCT-001; NCT01395147; hereinafter, OCT-001), if they meet all inclusion criteria and none of exclusion criteria of the OCT-001 study and are willing to participate in the OCT-001 study. Subjects who will enter the OCT-001 will not be requested to safety follow-up after completion of the 8-week double-blind treatment period.

Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S and Takeda for the treatment of major depressive disorder and general anxiety disorder.

Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity in the general population. The estimated lifetime prevalence of major depression in the adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in men. The hallmark of the disease is a depressed mood, with additional symptoms including sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss, concentration difficulties and delusional ideas. In addition to direct ill effects, MDD causes suicide or job loss and exerts indirect influence on social economy.

This study will assess the efficacy and the safety of Lu AA21004. This study consists of a 1-week screening period, an 8-week double-blind treatment period, 4-week s safety follow-up.The duration of the study is 13 weeks in total. Blood samples will be collected from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week double-blind treatment period.

Subjects who complete the 8-week double-blind treatment period can successively enter a long-term extension study (Lu AA21004/OCT-001; NCT01395147; hereinafter, OCT-001), if they meet all inclusion criteria and none of exclusion criteria of the OCT-001 study and are willing to participate in the OCT-001 study.

Subjects who will enter the OCT-001 will not be requested to safety follow-up after completion of the 8-week double-blind treatment period.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

366

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Japonia
      • Ibaraki, Japonia
      • Tokyo, Japonia
    • Chiba
      • Inzai-shi, Chiba, Japonia
      • Noda-City, Chiba, Japonia
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japonia
      • Kitakyushu-shi, Fukuoka, Japonia
    • Gunma
      • Annaka-shi, Gunma, Japonia
      • Fujioka-shi, Gunma, Japonia
      • Takasaki-shi, Gunma, Japonia
    • Hiroshima
      • Hatsukaichi-shi, Hiroshima, Japonia
      • Hiroshima-shi, Hiroshima, Japonia
    • Hokkaido
      • Sapporo-Shi, Hokkaido, Japonia
    • Hyogo
      • Amagasaki-shi, Hyogo, Japonia
      • Kobe-shi, Hyogo, Japonia
    • Kanagawa
      • Fujisawa-shi, Kanagawa, Japonia
      • Kawasaki-shi, Kanagawa, Japonia
      • Sagamihara-shi, Kanagawa, Japonia
      • Yokohama-shi, Kanagawa, Japonia
    • Kita-ku
      • Osaka-shi, Kita-ku, Japonia
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japonia
    • Kyoto
      • Kyoto-shi, Kyoto, Japonia
    • Okayama
      • Kurashiki-shi, Okayama, Japonia
    • Osaka
      • Osaka-shi, Osaka, Japonia
    • Saitama
      • Fukaya-shi, Saitama, Japonia
      • Saitama-city, Saitama, Japonia
    • Tochigi
      • Utsunomiya-shi, Tochigi, Japonia
    • Tokushima
      • Anan-shi, Tokushima, Japonia
      • Tokushisma-shi, Tokushima, Japonia
    • Tokyo
      • Hachioji-shi, Tokyo, Japonia
      • Katsushika-ku, Tokyo, Japonia
      • Musashino-shi, Tokyo, Japonia
    • Yamagata
      • Nanyo-shi, Yamagata, Japonia

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

20 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. The subject suffers from Major Depressive Disorder (MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x).
  2. The reported duration of the current major depressive episode is at least 3 months at the Screening Visit.
  3. The subject has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline Visits.
  4. The subject has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the Screening and Baseline Visits

Exclusion Criteria:

  1. The subject has one or more of the following conditions:

    • Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR. A subject who exhibits symptoms of anxiety is eligible unless the subject fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
    • Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
    • Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR.
    • Presence or history of a clinically significant neurological disorder (including epilepsy).
    • Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.).
    • Any DSM-IV-TR axis II disorder that might compromise the study.
  2. The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
  3. The subject is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS at the Screening and Baseline Visit, or has attempted suicide within 6 months prior to the Screening Visit.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Vortioxetine 5 mg
Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
Lek: Wortioksetyna
Tabletki wortioksetyny
Inne nazwy:
  • Lu AA21004
  • BRINTELLIX
Eksperymentalny: Vortioxetine 10 mg
Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
Lek: Wortioksetyna
Tabletki wortioksetyny
Inne nazwy:
  • Lu AA21004
  • BRINTELLIX
Komparator placebo: Placebo
Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
Lek: Placebo
Vortioxetine placebo
Inne nazwy:
  • Vortioxetine placebo-matching tablets

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment
Ramy czasowe: Baseline, Week 8
MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.
Baseline, Week 8

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Patients With MADRS Response After 8 Weeks of Treatment
Ramy czasowe: Baseline, Week 8
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline.
Baseline, Week 8
Percentage of Patients With MADRS Remission After 8 Weeks of Treatment
Ramy czasowe: Week 8
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Remission is defined as a MADRS Total Score ≤10.
Week 8
Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment
Ramy czasowe: Baseline, Week 8
The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52. Higher scores indicate greater severity of depression symptoms. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the baseline HAM-D17 score as a covariate.
Baseline, Week 8
Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment
Ramy czasowe: Baseline, Week 8
The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: "Compared to his condition at the start of the study, how much has this patient changed?" which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate.
Baseline, Week 8
Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment
Ramy czasowe: Baseline, Week 8
The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate.
Baseline, Week 8

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Takeda

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 maja 2011

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2012

Ukończenie studiów (Rzeczywisty)

1 grudnia 2012

Daty rejestracji na studia

Pierwszy przesłany

16 maja 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 maja 2011

Pierwszy wysłany (Oszacować)

17 maja 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

11 listopada 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 listopada 2014

Ostatnia weryfikacja

1 listopada 2014

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • LuAA21004/CCT-003
  • U1111-1120-9277 (Identyfikator rejestru: WHO)
  • JapicCTI-111492 (Identyfikator rejestru: JapicCTI)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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