- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00287027
Family Perspectives:Treatment of Psychiatric Illnesses With Atypical Long Acting Injectable Antipsychotic Medication
4. januar 2007 opdateret af: National Alliance on Mental Illness New Hampshire
Patients who have schizophrenia, schizoaffective disorder, a psychotic disorder, and are being treated with a medication called Risperidone Long Acting Injectable medication or another antipsychotic medication are candidates for the study.
The purpose of the study is to find out from patients' family how they feel the medication has affected their relationship with them.
The study will involve meeting with family members three times over the course of one year.
The first time will be at New Hampshire Hospital (NHH) or at a community mental health center and the follow up times will be at a convenient place and time for the family member (s), in the community.
We will ask them to answer questions from the Family Burden Interview and Quality of Life Questionnaire.
The family will not be charged for any test that is completed solely for this study.
The family will be provided a travel stipend to meet with the researchers.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients who have schizophrenia, schizoaffective disorder, a psychotic disorder, and are being treated with a medication called Risperidone Long Acting Injectable medication or another antipsychotic medication are candidates for the study.
The purpose of the study is to find out from patients' family how they feel the medication has affected their relationship with them.The study will involve meeting with family members three times over the course of one year.
The first time will be at New Hampshire Hospital (NHH) or at a community mental health center and the follow up times will be at a convenient place and time for the family member (s), in the community.
We will ask them to answer questions from the Family Burden Interview and Quality of Life Questionnaire.
The family will not be charged for any test that is completed solely for this study.
The family will be provided a travel stipend to meet with the researchers.We do not see that there will be any risks to the family.
We will be interviewing the patient's family, and they will be sharing information as to how they feel their relationship with the patient is going.
All efforts will be made to keep this information confidential; however, there may be unforeseen circumstances that could lead to breaching of confidentiality.
If the family expresses need for help the research staff will make recommendations for referral to a provider.
Undersøgelsestype
Observationel
Tilmelding
60
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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New Hampshire
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Concord, New Hampshire, Forenede Stater, 03301
- NAMI NH
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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 til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Inclusion criteria:Families of adults between the ages of 18-65 who have a diagnosis of Schizophrenia, Schizoaffective Disorder, Psychotic Disorder NOS, and whose loved one gave permission for them to be contacted.
- Either a) a family member whose adult consumer started on Risperidone Long Acting Injection within one month, while at New Hampshire Hospital and/or at a Community Mental Health Center and who consented to participate; or b) a family member whose adult consumer was switched from one antipsychotic medication to another (excluding clozapine) within one month, while at New Hampshire Hospital and/or at a Community Mental Health Center and who consented to participate.
- Families that have at least 4 hours per week contact with their loved one with mental illness for 2 of the 4 weeks preceding the medication change.
Exclusion Criteria:
-
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Defineret befolkning
- Tidsperspektiver: Fremadrettet
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alex deNesnera, MD, Dartmouth-Hitchcock Medical Center
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. februar 2006
Studieafslutning
1. december 2006
Datoer for studieregistrering
Først indsendt
2. februar 2006
Først indsendt, der opfyldte QC-kriterier
2. februar 2006
Først opslået (Skøn)
6. februar 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. januar 2007
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. januar 2007
Sidst verificeret
1. januar 2007
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CPHS#17558
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 .