Observationsundersøgelse i flere lande for at indsamle hyppigheden af seksuel dysfunktion med antidepressiv behandling, enten med SSRI'er eller dobbelte efter 8 uger og 6 måneder
13. juli 2009 opdateret af: Eli Lilly and Company
En prospektiv, observationel undersøgelse, der sammenligner hyppigheden af behandlingsfremkaldt seksuel dysfunktion over 8 uger hos patienter med svær depressiv lidelse behandlet med enten duloxetinhydrochlorid eller et selektivt serotonin-genoptagelseshæmmer antidepressivt middel og evalueret over 6 måneder
Under sædvanlige kliniske tilstande vil deprimerede patienter uden seksuel dysfunktion, efter at have underskrevet deres samtykke til formidling af deres kliniske information, begynde deres behandling med et hvilket som helst SSRI eller et dobbelt antidepressivum i henhold til den bedste kliniske beslutning fra deres behandlende psykiater.
Seksuel dysfunktion vil blive identificeret i løbet af de 6 måneders aktiv observation.
Psykiatere vil beslutte at ændre dosis, øge, skifte eller kombinere antidepressiva efter deres kliniske skøn til fordel for deres patienter, og alle kliniske beslutninger vil blive registreret. Sammenligninger mellem antidepressiva vil blive foretaget med hensyn til deres potentiale for seksuel dysfunktion.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1626
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Lucena, Filippinerne
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Makati, Filippinerne
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Pasig City, Filippinerne
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Quezon City, Filippinerne
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Abu Dhabi, Forenede Arabiske Emirater
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Dubai, Forenede Arabiske Emirater
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Pokfulam, Hong Kong
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Bat Yam, Israel
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Beer Sheva, Israel
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Haifa, Israel
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Herzliya, Israel
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Hod Hasharon, Israel
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Ramat Gan, Israel
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Beijing, Kina
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Guangzhou, Kina
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Harbin, Kina
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Hong Kong, Kina
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Jinan, Kina
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Shanghai, Kina
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Suzhou, Kina
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Wuhan, Kina
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Beirut, Libanon
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Kuala Lumpur, Malaysia
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Cancun, Mexico
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Guadalajara, Mexico
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Leon, Mexico
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Merida, Mexico
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Mexicali, Mexico
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Mexico City, Mexico
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Monterrey, Mexico
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Morelia, Mexico
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Puebla, Mexico
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San Luis Potosi, Mexico
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Tijuana, Mexico
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Torreon, Mexico
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Victoria, Mexico
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Villahermosa, Mexico
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Dammam, Saudi Arabien
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Jeddah, Saudi Arabien
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Khamis Mushayt, Saudi Arabien
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Madina, Saudi Arabien
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Makkah, Saudi Arabien
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Riyadh, Saudi Arabien
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Singapore, Singapore
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Hualien, Taiwan
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Neihu Taipei, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Bangkok, Thailand
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Innsbruck, Østrig
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Jenbach, Østrig
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Salzburg, Østrig
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Spital/Drau, Østrig
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Steyr, Østrig
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Vienna, Østrig
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Wels, Østrig
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Wolfsberg, Østrig
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patientpopulationen vil bestå af seksuelt aktive mandlige og kvindelige patienter, 18 år eller ældre med en primær diagnose MDD, for hvem den behandlende kliniker træffer beslutning om at behandle med et SSRI- eller SNRI-antidepressivum.
Berettigede patienter skal acceptere at deltage i indsamlingen af data og må ikke have behandlingsresistent depression eller have seksuel dysfunktion ved indgangen til undersøgelsen.
Beskrivelse
Inklusionskriterier:
- Opfyld kriterierne for MDD, som defineret af ICD-10 eller DSM-IV-TR
- Er mindst moderat deprimeret (baseline CGI-S mindre end eller lig med 4)
- Giv skriftligt samtykke til frigivelse af deres data efter at være blevet informeret om undersøgelsen
- Tilstede med en episode af MDD (aktuel, ny eller første episode) inden for det normale behandlingsforløb, og accepterer at påbegynde antidepressiv behandling med enhver tilgængelig SSRI- eller SNRI-klasse af antidepressiva i overensstemmelse med investigatorens beslutning om behandling af patienten
- Har været seksuelt aktiv i ugen før tilmelding, enten med en partner eller autoerotisk aktivitet
Ekskluderingskriterier:
- Opfyld et af følgende kriterier for seksuel dysfunktion ved studiestart (McGahuey et al. 2000: ASEX-score mindre end eller lig med 19 eller ASEX-score mindre end eller lig med 5 på ethvert emne, eller ASEX-score mindre end eller lig med 4 på alle 3 emner
- Deltager samtidig i en anden undersøgelse, der inkluderer en behandlingsintervention og/eller et forsøgslægemiddel
- Har en historie med behandlingsresistent depression (TRD) defineret som manglende respons på 2 forskellige antidepressiva fra forskellige klasser efter behandling med terapeutisk dosis i mindst 4 uger
- Har nogen tidligere eller nuværende diagnose af skizofreni, skizofreniform eller skizoaffektiv lidelse, bipolar lidelse, dystymi, mental retardering eller demens
- Har modtaget antidepressiva inden for 1 uge før tilmelding (1 måned før tilmelding til fluoxetin)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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EN
SSRI'er
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Anvendes inden for normal klinisk praksis
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B
Dobbelt antidepressiva
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Brug i klinisk praksis
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Hyppighed af seksuel dysfunktion på grund af behandling med enten SSRI eller dobbelte antidepressiva
Tidsramme: 8 uger
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8 uger
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Hyppighed af seksuel dysfunktion sammen med behandling med SSRI eller dobbelte antidepressiva
Tidsramme: 6 måneder
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6 måneder
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Sygdommens sværhedsgrad
Tidsramme: 6 måneder
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6 måneder
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Ressourceudnyttelse
Tidsramme: 6 måneder
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6 måneder
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Livskvalitet
Tidsramme: 6 måneder
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6 måneder
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Overholdelse af behandling
Tidsramme: 6 måneder
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6 måneder
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Identificer faktorer relateret til seksuel dysfunktion
Tidsramme: 6 måneder
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6 måneder
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
Hjælpsomme links
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 2007
Studieafslutning (Faktiske)
1. juni 2009
Datoer for studieregistrering
Først indsendt
19. november 2007
Først indsendt, der opfyldte QC-kriterier
19. november 2007
Først opslået (Skøn)
21. november 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. juli 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. juli 2009
Sidst verificeret
1. juli 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11539
- F1J-MC-B019
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 .