En langsiktig, åpen studie om schizofreni
10. september 2026 oppdatert av: Denovo Biopharma LLC
En langsiktig, åpen, multisenterstudie av LY2140023 sammenlignet med atypisk antipsykotisk behandlingsstandard hos pasienter med DSM-IV-TR schizofreni
Hovedformålet med studien er å bidra til å besvare følgende forskningsspørsmål:
Hvordan LY 2140023 kan tolereres av pasienter med schizofreni sammenlignet med standardbehandling i løpet av 52 uker.
Om LY 2140023 kan hjelpe pasienter med schizofreni.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studien omfatter 2 behandlingsperioder.
Studieperiode I vil begynne ved randomisering av pasient (registrering til studie HBBO) og fortsette gjennom de første 2 årene av behandlingen.
Studieperiode II vil kun være for pasienter randomisert til behandling med LY2140023, og vil begynne etter at pasienten har fullført andre behandlingsår.
Pasienter som kvalifiserer for registrering vil randomiseres i forholdet 3:1 (henholdsvis LY2140023 versus standardbehandling) i 2 behandlingsgrupper: fleksibel, to ganger daglig dose av LY2140023 eller standardbehandling (olanzapin, risperidon, aripiprazol, eller quetiapin).
De som er tildelt LY2140023 vil ha muligheten til å fortsette på LY2140023 etter 2 år hvis etterforskeren anser det som hensiktsmessig.
Studietype
Intervensjonell
Registrering (Faktiske)
560
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arkansas
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Little Rock, Arkansas, Forente stater, 72201
- 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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California
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Escondido, California, Forente stater, 92025
- 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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Garden Grove, California, Forente stater, 92845
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Long Beach, California, Forente stater, 90813
- 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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National City, California, Forente stater, 91950
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Oakland, California, Forente stater, 94612
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Oceanside, California, Forente stater, 92056
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Paramount, California, Forente stater, 90723
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Pasadena, California, Forente stater, 91106
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San Diego, California, Forente stater, 92123
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Sherman Oaks, California, Forente stater, 91403
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Torrance, California, Forente stater, 90502
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20016
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Florida
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Fort Lauderdale, Florida, Forente stater, 33308
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Hollywood, Florida, Forente stater, 33021
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Kissimmee, Florida, Forente stater, 34741
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Maitland, Florida, Forente stater, 32751
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University Park, Florida, Forente stater, 34201
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Georgia
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Atlanta, Georgia, Forente stater, 30308
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Illinois
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Chicago, Illinois, Forente stater, 60640
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Hoffman Estates, Illinois, Forente stater, 60169
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Indiana
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Indianapolis, Indiana, Forente stater, 46222
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Kansas
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Wichita, Kansas, Forente stater, 67207
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Louisiana
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Lake Charles, Louisiana, Forente stater, 70629
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Shreveport, Louisiana, Forente stater, 71104
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Mississippi
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Flowood, Mississippi, Forente stater, 39232
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Missouri
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Creve Coeur, Missouri, Forente stater, 63141
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New Jersey
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Marlton, New Jersey, Forente stater, 08053
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New York
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Buffalo, New York, Forente stater, 14215
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Cedarhurst, New York, Forente stater, 11516
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Holliswood, New York, Forente stater, 11423
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New York, New York, Forente stater, 10032
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Rochester, New York, Forente stater, 14615
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
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Dayton, Ohio, Forente stater, 45417
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19139
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Texas
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Austin, Texas, Forente stater, 78754
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Dallas, Texas, Forente stater, 75243
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DeSoto, Texas, Forente stater, 75115
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Houston, Texas, Forente stater, 77008
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Virginia
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Richmond, Virginia, Forente stater, 23298
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Roanoke, Virginia, Forente stater, 24014
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Aichi, Japan, 470-1168
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Kanagawa, Japan, 210-0013
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Kumamoto, Japan, 861-0002
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Kyoto, Japan, 625-8502
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Nagano, Japan, 384-8540
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Nagasaki, Japan, 856-0847
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Nara, Japan, 634-8522
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Osaka, Japan, 569-1041
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Saga, Japan, 842-0192
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Tokyo, Japan, 120-0033
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Toyama, Japan, 939-8073
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Zagreb, Kroatia, 10090
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Guadalajara, Mexico, 44340
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Monterrey, Mexico, 64060
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Ponce, Puerto Rico, 00731
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San Juan, Puerto Rico, 00926
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Khot'kovo, Russland, 127025
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Lipetsk, Russland, 399007
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Moscow, Russland, 115522
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Nizhny Novgorod, Russland, 603155
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Saint Petersburg, Russland, 190121
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Samara, Russland, 443016
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Saratov, Russland, 410060
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Tomsk, Russland, 634014
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Voronezh, Russland, 394071
- 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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Yaroslavl, Russland, 150003
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Goyang-si, Sør -Korea, 410-719
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Incheon, Sør -Korea, 400-711
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Naju, Sør -Korea, 520-833
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Seoul, Sør -Korea, 150-713
- 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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Suwon, Sør -Korea, 442-723
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Yongin, Sør -Korea, 446-769
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Changhua, Taiwan, 50550
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Neihu District, Taiwan, 114
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Taipei, Taiwan, 100
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Donetsk, Ukraina, 83037
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Kherson, Ukraina, 73488
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Kiev, Ukraina, 2660
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Vinnytsia, Ukraina, 21005
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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 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Må ha oppfylt alle inngangskriterier for, og ha fullført, en akutt, placebokontrollert klinisk studie av LY2140023 (slik som studie H8Y-MC-HBBM, eller andre akutte, placebokontrollerte LY2140023 studier hvis tillatt av protokollene for disse studiene) .
- Kvinnelige pasienter i fertil alder må godta å bruke én enkelt, effektiv, medisinsk akseptabel prevensjonsmetode.
- Pasienter må anses som pålitelige og har et nivå av forståelse som er tilstrekkelig til å utføre alle tester og undersøkelser som kreves av protokollen.
- Pasienter må være i stand til å forstå studiens natur og ha gitt sitt eget informerte samtykke.
Ekskluderingskriterier:
- Er for øyeblikket registrert i, eller avbrutt i løpet av de siste 30 dagene fra en klinisk utprøving som involverer et undersøkelsesprodukt eller ikke-godkjent bruk av et medikament eller en enhet (annet enn LY2140023), eller samtidig påmeldt noen annen type medisinsk forskning som vurderes å ikke være vitenskapelig eller medisinsk forenlig med denne studien.
- Pasienter der behandling med olanzapin, risperidon, aripiprazol, quetiapin eller LY2140023, som spesifisert i denne protokollen, er relativt eller absolutt klinisk kontraindisert.
- Pasienter som har fått behandling med klozapin i doser større enn 200 mg daglig innen 12 måneder før studieregistrering, eller som i det hele tatt har fått noe klozapin i løpet av måneden før studieregistrering.
- Pasienter som trenger samtidig behandling med andre medikamenter med primær sentralnervesystemaktivitet, annet enn det som er tillatt i studieprotokollen.
- Pasienter har risiko for selvmord.
- Pasienter diagnostisert med rusavhengighet eller rusmisbruk innen 6 måneder før studieregistrering.
- Pasienter diagnostisert med substansindusert psykose innen 7 dager etter studieregistrering eller når som helst i løpet av studien.
- Kvinnelige pasienter som er gravide, ammer, ammer eller har til hensikt å bli gravide innen 30 dager etter at studien er fullført.
- Har kjent glaukom.
- Har en historie med noen typer anfall.
- Har anfallsansvar som er i strid med eksklusjonskriteriene for den fullførte akuttmaterstudien.
- Pasienter som har hatt elektrokonvulsiv terapi (ECT) innen 3 måneder etter studieregistrering eller som vil ha ECT når som helst i løpet av studien.
- Pasienter med kjent Human Immunodeficiency Virus positiv (HIV+) status.
- Pasienter har en alvorlig sykdom, som nylig hjerneslag, hjerte-, lever-, nyre-, lunge- eller blodsykdommer
- Pasienter med Parkinsons sykdom
- Er ute av stand til å delta i studien eller er uvillige til å engasjere seg på en meningsfull måte som studiedeltakere.
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Velferdstandard
|
Tabletter eller kapsler, gitt oralt, i samsvar med godkjent merking og lokal praksis i 104 uker
Andre navn:
Tabletter eller kapsler, gitt oralt, i samsvar med godkjent merking og lokal praksis i 104 uker
Tabletter eller kapsler, gitt oralt, i samsvar med godkjent merking og lokal praksis i 104 uker
Tabletter eller kapsler, gitt oralt, i samsvar med godkjent merking og lokal praksis i 104 uker
|
|
Eksperimentell: LY2140023
20 milligram (mg), 40mg or 80mg After 104 weeks, participants have the option to continue on treatment until the end of the study |
Administrert oralt, to ganger daglig i 104 uker
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Tid til seponering på grunn av uønskede hendelser
Tidsramme: Baseline gjennom 52 uker
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Baseline gjennom 52 uker
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Endring fra baseline til 52 ukers endepunkt i PANSS (Positive and Negative Syndrome Scale)
Tidsramme: Utgangspunkt, 52 uker
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Utgangspunkt, 52 uker
|
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Endring fra baseline til 52 ukers endepunkt i Clinical Global Impression-Severity (CGI-S)
Tidsramme: Utgangspunkt, 52 uker
|
Utgangspunkt, 52 uker
|
|
Endring fra baseline til 52 ukers endepunkt i NSA-16 (16-element Negative Symptom Assessment)
Tidsramme: Utgangspunkt, 52 uker
|
Utgangspunkt, 52 uker
|
|
Antall pasienter med statistisk signifikante endringer (behandlingsfremkallende ideer og atferd; forbedring) basert på Columbia Suicide Severity Rating Scale (C-SSRS)
Tidsramme: 52 uker, 104 uker, studieslutt
|
52 uker, 104 uker, studieslutt
|
|
Endring fra baseline til 52 ukers endepunkt i PSP-skala (Personlig og sosial ytelse)
Tidsramme: Utgangspunkt, 52 uker
|
Utgangspunkt, 52 uker
|
|
Endring fra baseline til 52 ukers endepunkt i SWN-skalaen (subjektivt velvære under nevroleptisk behandling)
Tidsramme: Utgangspunkt, 52 uker
|
Utgangspunkt, 52 uker
|
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Endring fra baseline til 104 ukers endepunkt i Schizophrenia Resource Use Model (S-RUM)
Tidsramme: Utgangspunkt, 104 uker
|
Utgangspunkt, 104 uker
|
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Endring fra baseline til 104 ukers endepunkt i EuroQoL Questionnaire-5 Dimension (EQ-5D)
Tidsramme: Utgangspunkt, 104 uker
|
Utgangspunkt, 104 uker
|
|
Endring fra 52 uker til 104 ukers endepunkt i PANSS (Positive and Negative Syndrome Scale)
Tidsramme: 52 uker, 104 uker
|
52 uker, 104 uker
|
|
Endring fra 52 uker til 104 ukers endepunkt i Clinical Global Impression-Severity (CGI-S)
Tidsramme: 52 uker, 104 uker
|
52 uker, 104 uker
|
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Endring fra 52 uker til 104 ukers endepunkt i NSA-16 (16-element Negative Symptoms Assessment)
Tidsramme: 52 uker, 104 uker
|
52 uker, 104 uker
|
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Endring fra 104 uker til studieendepunkt i Clinical Global Impression-Severity (CGI-S)
Tidsramme: 104 uker, studieslutt
|
104 uker, studieslutt
|
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Endring fra baseline til 104 ukers endepunkt i PSP-skala (Personlig og sosial ytelse)
Tidsramme: Utgangspunkt, 104 uker
|
Utgangspunkt, 104 uker
|
|
Endring fra baseline til 104 ukers endepunkt i SWN-skalaen (subjektivt velvære under nevroleptisk behandling)
Tidsramme: Utgangspunkt, 104 uker
|
Utgangspunkt, 104 uker
|
|
Endring fra baseline til 52 ukers endepunkt i Schizophrenia Resource Use Model (S-RUM)
Tidsramme: Utgangspunkt, 52 uker
|
Utgangspunkt, 52 uker
|
|
Endre fra 104 uker til studieendepunkt i EuroQoL Questionnaire-5 Dimension (EQ-5D)
Tidsramme: 104 uker, studieslutt
|
104 uker, studieslutt
|
|
Endring fra baseline til 52 ukers endepunkt i PANSS (Positive and Negative Syndrome Scale) i en genetisk definert undergruppe
Tidsramme: Baseline, 52 uker
|
Baseline, 52 uker
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
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. juni 2010
Primær fullføring (Faktiske)
1. oktober 2012
Studiet fullført (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først innsendt
21. mai 2010
Først innsendt som oppfylte QC-kriteriene
21. mai 2010
Først lagt ut (Antatt)
25. mai 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. september 2026
Sist bekreftet
1. oktober 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Schizofrenispektrum og andre psykotiske lidelser
- Psykiske lidelser
- Schizofreni
- Svovelforbindelser
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Pyrimidiner
- Pyrimidinoner
- Benzazepiner
- Kinoloner
- Kinoliner
- Benzodiazepiner
- Heterocykliske forbindelser, 3-ring
- Piperazines
- Dibenzothiazepines
- Tiazepiner
- Thiepins
- Olanzapin
- Aripiprazol
- Quetiapinfumarat
- Risperidon
- LY 2140023
Andre studie-ID-numre
- 11960 (DAIDS-ES Registry Number)
- H8Y-MC-HBBO (Annen identifikator: Eli Lilly and Company)
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. .