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

31. oktober 2013 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

356

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • Forente stater
    • California
      • Costa Mesa, California, Forente stater, 92647
        • Clinical Innovations, Inc.
      • Riverside, California, Forente stater, 92506
        • Clinical Innovations Inc.
      • San Diego, California, Forente stater, 92123
        • Sharp Mesa Vista Hospital
      • San Diego, California, Forente stater, 92123
        • Artemis Institute for Clinical Research
      • Santa Ana, California, Forente stater, 92705
        • Clinical Innovations Inc.
      • Torrance, California, Forente stater, 90502
        • Collaborative Neuroscience Network
    • Colorado
      • Highlands Ranch, Colorado, Forente stater, 80130
        • Colorado Clinical Trials Inc.
    • Florida
      • Kissimmee, Florida, Forente stater, 34741
        • Accurate Clinical Trials
      • Orlando, Florida, Forente stater, 32806
        • Clinical Neuroscience Solutions Inc.
    • Georgia
      • Roswell, Georgia, Forente stater, 30076
        • Northwest Behavioral Research Center
      • Smyrna, Georgia, Forente stater, 30080
        • Institute for Behavioral Medicine LLC
    • Mississippi
      • Flowood, Mississippi, Forente stater, 39232
        • Precise Research Centers
    • New York
      • New York, New York, Forente stater, 10003
        • Village Clinical Research Inc.
      • New York, New York, Forente stater, 10023
        • Medical & Behavioral Health Research
    • North Carolina
      • Raleigh, North Carolina, Forente stater, 27607
        • Zarzar Psychiatric Associates, Pllc
    • Oregon
      • Portland, Oregon, Forente stater, 97210
        • Summit Research Network (Oregon) Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18103
        • LeHigh Valley Hospital
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Dallas, Texas, Forente stater, 75231
        • FutureSearch Clinical Trials, LP
      • Dallas, Texas, Forente stater, 75243
        • Pillar Clinical Research
      • Houston, Texas, Forente stater, 77090
        • Red Oak Psychiatry Associates, PA
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Summit Research Network (Seattle) Llc
  • India
    • Andh Prad
      • Vishakhapatnam, Andh Prad, India, 530002
        • Brain Mind Behavior Neuroscience Research Institute
    • Aurangabad, Maharashtra
      • Kanchanpalli, Aurangabad, Maharashtra, India
        • Shanti Nursing Home
    • Gujarat
      • Vadodara, Gujarat, India, 390001
        • SBKS Medical College and Hospital, Brij Psychiatry Hospital
    • Karna
      • Bangalore, Karna, India, 560027
        • Abhaya Hospital Psychiatry
      • Mangalore, Karna, India, 575018
        • K.S. Hegde Medical Academy
    • Mahara
      • Pune, Mahara, India, 411 030
        • Poona Hospital & Research Center
      • Wardha, Mahara, India, 442102
        • Mahatma Ghandi Institute of Medical Sciences
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
        • Mental Health Care & Research
      • Jaipur, Rajasthan, India, 302021
        • R.K. Yadav Memorial Mental Health & De-Addiction Hospital
    • Uttar Prad
      • Kanpur, Uttar Prad, India, 208005
        • Mahendru Psychiatric Center
    • Utter Prad
      • Lucknow, Utter Prad, India, 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 Hipolito Unanue
      • Lima, Peru, 41
        • Clinica Vesalio
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • Centrum zdravia R. B. K. s.r.o.
      • Bojnice, Slovakia, 97201
        • Bojniciach
      • Bratislava, Slovakia, 82007
        • Psychiatricka Ambulancia Mentum S.R.O.
      • Bratislava, Slovakia, 82606
        • FNsP Bratislava, Nemocnica Ruzinov
      • Liptovsky Mikulas, Slovakia, 03123
        • Nemocnica s poliklinikou Liptovsky Milulas
      • Rimavska Sobota, Slovakia, 97901
        • PsychoLine s.r.o.
      • Roznava, Slovakia, 048 01
        • Nemocnica s poliklikou Sv. Barbory
      • Trencin, Slovakia, 91101
        • Pro mente sana
  • Tsjekkisk Republikk
      • Brno-mesto, Tsjekkisk Republikk, 602 00
        • Psychiatricka ambulance
      • Olomouc, Tsjekkisk Republikk, 711 11
        • Vojenska nemocnice Olomouc
      • Praha, Tsjekkisk Republikk, 10 100 00
        • CLINTRIAL, s.r.o.
      • Praha, Tsjekkisk Republikk, 158 00
        • Psychiatry Trial s.r.o.
  • Ukraina
      • Dnipropetrovsk, Ukraina, 49005
        • Dnipropetrovsk Regional Clinical Hospital named Mechnikov
      • Dnipropetrovsk, Ukraina, 49115
        • Com Inst Knipropetrovsk Reg Cl Psych Hospital DSMA
      • Kharkov, Ukraina
        • St. In. Inst of Neurol, Psych, and Narcol of the AMSU
      • Kyiv, Ukraina, 02660
        • Kyiv City Psychoneurological Hospital #2
      • Lviv, Ukraina, 79021
        • Lviv Regional Clinical Psychiatric Hospital
      • Ternopil, Ukraina, 46020
        • Ternopil Regional Municipal Dispensary, Narcology Dept.
      • Zaporizhzhya, Ukraina, 69032
        • Zapor. Reg. CI Hospital, Zaporizhzhia SMU
    • Vil Stepanivka
      • Kherson, Vil Stepanivka, Ukraina, 73488
        • Kherson Regional Psychiatric Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Legemiddel: Placebo
Equivalent to Lurasidone dosing
Eksperimentell: Lurasidone 20-120 mg flexible dose
Legemiddel: Lurasidone
Tablets 20-120 mg, PM dosing,daily for 6 weeks
Andre navn:
  • Latuda

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sunovion

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2010

Primær fullføring (Faktiske)

1. august 2012

Studiet fullført (Faktiske)

1. august 2012

Datoer for studieregistrering

Først innsendt

25. januar 2011

Først innsendt som oppfylte QC-kriteriene

25. januar 2011

Først lagt ut (Anslag)

27. januar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. november 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. oktober 2013

Sist bekreftet

1. oktober 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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