Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression (PREVAIL3)

31. oktober 2013 opdateret af: Sunovion

A Randomized, 6-week Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.

Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

356

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6L 6W6
        • Clinical Research Group Edmonton Inc
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Okanagan Clinical Trials
    • Quebec
      • Gatineau, Quebec, Canada, J9A 1K7
        • Pierre-Janet Hospital
      • Montreal, Quebec, Canada, H1N 3M5
        • Hopital Louis-H Lafontaine
  • Colombia
      • Barranquilla, Colombia
        • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
      • Bogota, Colombia, 103
        • Centro de Investigación y Atención para la Salud Mental
      • Bogota, Colombia
        • CISNE - UIC Campo Abierto
      • Cali, Colombia
        • Hospital Mental de Antioquia
  • Forenede Stater
    • California
      • Costa Mesa, California, Forenede Stater, 92647
        • Clinical Innovations, Inc.
      • Riverside, California, Forenede Stater, 92506
        • Clinical Innovations Inc.
      • San Diego, California, Forenede Stater, 92123
        • Sharp Mesa Vista Hospital
      • San Diego, California, Forenede Stater, 92123
        • Artemis Institute for Clinical Research
      • Santa Ana, California, Forenede Stater, 92705
        • Clinical Innovations Inc.
      • Torrance, California, Forenede Stater, 90502
        • Collaborative Neuroscience Network
    • Colorado
      • Highlands Ranch, Colorado, Forenede Stater, 80130
        • Colorado Clinical Trials Inc.
    • Florida
      • Kissimmee, Florida, Forenede Stater, 34741
        • Accurate Clinical Trials
      • Orlando, Florida, Forenede Stater, 32806
        • Clinical Neuroscience Solutions Inc.
    • Georgia
      • Roswell, Georgia, Forenede Stater, 30076
        • Northwest Behavioral Research Center
      • Smyrna, Georgia, Forenede Stater, 30080
        • Institute for Behavioral Medicine LLC
    • Mississippi
      • Flowood, Mississippi, Forenede Stater, 39232
        • Precise Research Centers
    • New York
      • New York, New York, Forenede Stater, 10003
        • Village Clinical Research Inc.
      • New York, New York, Forenede Stater, 10023
        • Medical & Behavioral Health Research
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Zarzar Psychiatric Associates, Pllc
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Summit Research Network (Oregon) Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Lehigh Valley Hospital
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Dallas, Texas, Forenede Stater, 75231
        • FutureSearch Clinical Trials, LP
      • Dallas, Texas, Forenede Stater, 75243
        • Pillar Clinical Research
      • Houston, Texas, Forenede Stater, 77090
        • Red Oak Psychiatry Associates, PA
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Summit Research Network (Seattle) Llc
  • Indien
    • Andh Prad
      • Vishakhapatnam, Andh Prad, Indien, 530002
        • Brain Mind Behavior Neuroscience Research Institute
    • Aurangabad, Maharashtra
      • Kanchanpalli, Aurangabad, Maharashtra, Indien
        • Shanti Nursing Home
    • Gujarat
      • Vadodara, Gujarat, Indien, 390001
        • SBKS Medical College and Hospital, Brij Psychiatry Hospital
    • Karna
      • Bangalore, Karna, Indien, 560027
        • Abhaya Hospital Psychiatry
      • Mangalore, Karna, Indien, 575018
        • K.S. Hegde Medical Academy
    • Mahara
      • Pune, Mahara, Indien, 411 030
        • Poona Hospital & Research Center
      • Wardha, Mahara, Indien, 442102
        • Mahatma Ghandi Institute of Medical Sciences
    • Rajasthan
      • Jaipur, Rajasthan, Indien, 302017
        • Mental Health Care & Research
      • Jaipur, Rajasthan, Indien, 302021
        • R.K. Yadav Memorial Mental Health & De-Addiction Hospital
    • Uttar Prad
      • Kanpur, Uttar Prad, Indien, 208005
        • Mahendru Psychiatric Center
    • Utter Prad
      • Lucknow, Utter Prad, Indien, 226003
        • Chatrapati Shau Maharaj Medical University
  • Japan
      • Hachioji-shi, Japan, 192 0153, 13
        • Ongata Hospital
      • Ichikawa, Japan, 272 8516 12
        • Kohnodai Hospital, National Center for Global Health & Medicine
      • Kanzaki-gun, Japan, 842 0192 41
        • National Hospital Organization Hizen Psychiatric Center
      • Kodaira-shi, Japan, 187 8551 13
        • National Center of Neurology & Psychiatry
      • Sakai-shi, Japan, 590 0018, 27
        • Asakayama General Hospital
      • Takatsuki, Japan, 569-1041
        • Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital
  • Litauen
      • Kaunas, Litauen, 50185
        • Neuromeda JSC
      • Kaunas, Litauen, 53136
        • Ziegzdriai Mental Hospital, Public Institution
      • Silute, Litauen, 99142
        • Silutes Mental Health & Psychtherapy Center, JSC
      • Vilnius, Litauen, 07156
        • Seskines Outpatient Clinic, Public Institution
      • Vilnius, Litauen, 09112
        • Zirmunai Mental Health Center, Public Institution
  • Peru
      • Lima, Peru, 01
        • Hospital Nacional Arzobispo Loayza
      • Lima, Peru, 27
        • Hospital Nacional Hipólito Unanue
      • Lima, Peru, 41
        • Clinica Vesalio
  • Slovakiet
      • Bardejov, Slovakiet, 085 01
        • Centrum zdravia R. B. K. s.r.o.
      • Bojnice, Slovakiet, 97201
        • Bojniciach
      • Bratislava, Slovakiet, 82007
        • Psychiatricka Ambulancia Mentum S.R.O.
      • Bratislava, Slovakiet, 82606
        • FNsP Bratislava, Nemocnica Ruzinov
      • Liptovsky Mikulas, Slovakiet, 03123
        • Nemocnica s poliklinikou Liptovsky Milulas
      • Rimavska Sobota, Slovakiet, 97901
        • PsychoLine s.r.o.
      • Roznava, Slovakiet, 048 01
        • Nemocnica s poliklikou Sv. Barbory
      • Trencin, Slovakiet, 91101
        • Pro mente sana
  • Tjekkiet
      • Brno-mesto, Tjekkiet, 602 00
        • Psychiatricka ambulance
      • Olomouc, Tjekkiet, 711 11
        • Vojenska nemocnice Olomouc
      • Praha, Tjekkiet, 10 100 00
        • CLINTRIAL, s.r.o.
      • Praha, Tjekkiet, 158 00
        • Psychiatry Trial s.r.o.
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • Dnipropetrovsk Regional Clinical Hospital named Mechnikov
      • Dnipropetrovsk, Ukraine, 49115
        • Com Inst Knipropetrovsk Reg Cl Psych Hospital DSMA
      • Kharkov, Ukraine
        • St. In. Inst of Neurol, Psych, and Narcol of the AMSU
      • Kyiv, Ukraine, 02660
        • Kyiv City Psychoneurological Hospital #2
      • Lviv, Ukraine, 79021
        • Lviv Regional Clinical Psychiatric Hospital
      • Ternopil, Ukraine, 46020
        • Ternopil Regional Municipal Dispensary, Narcology Dept.
      • Zaporizhzhya, Ukraine, 69032
        • Zapor. Reg. CI Hospital, Zaporizhzhia SMU
    • Vil Stepanivka
      • Kherson, Vil Stepanivka, Ukraine, 73488
        • Kherson Regional Psychiatric Hospital

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Provide written informed consent and is 18 to 75 years of age inclusive.
  2. Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
  3. Has a lifetime history of at least one bipolar manic or mixed manic episode.
  4. Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
  5. Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
  6. Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
  7. Good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion Criteria:

  1. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
  2. Any chronic organic disease of the CNS (other than Bipolar I Disorder).
  3. Hospitalization for a manic or mixed episode within the past two months.
  4. Used investigational compound within past 6 months.
  5. Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Equivalent to Lurasidone dosing
Eksperimentel: Lurasidone 20-120 mg flexible dose
Medicin: Lurasidone
Tablets 20-120 mg, PM dosing,daily for 6 weeks
Andre navne:
  • Latuda

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
Tidsramme: Baseline to week 6
MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Baseline to week 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
Tidsramme: Baseline to week 6
CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Baseline to week 6
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Tidsramme: Baseline to week 6
SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Baseline to week 6

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sunovion

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

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. november 2010

Primær færdiggørelse (Faktiske)

1. august 2012

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

25. januar 2011

Først indsendt, der opfyldte QC-kriterier

25. januar 2011

Først opslået (Skøn)

27. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D1050292
  • 2010-019778-34 (EudraCT nummer)

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 .

Kliniske forsøg med Bipolar depression

Kliniske forsøg med Lurasidone

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Netherlands

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner