- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00334035
Antipsychotic Therapy and First Episode
17. februar 2011 opdateret af: The University of Hong Kong
Duration of Maintenance Anti-psychotic Therapy After First -Episode Schizophrenia: a Double-blind Randomized Placebo-control Relapse Prevention Study
For schizophrenic patients who remained in remission while on maintenance medication, there may come a point in time when the relative risk for relapse become so low that discontinuation of therapy can be considered.
This study is to investigate whether that point in time is reached in 12 months following the first episode illness.
Moreover, it also aims to identify other predictors of relapse as well as to evaluate the costs and benefits of maintenance therapy.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
169
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hong Kong, Hong Kong
- Research Site
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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:
- Male or female patients, from 18 to 65 years of age at Visit 1
- Patients must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing.
- Patients must agree to cooperate with all tests and examinations required by the protocol. They must be willing to comply fully with treatment
- Patient must understand the nature of the study and must sign an informed consent document.
- Patients must be Cantonese speaking Han Chinese
- Patients must be diagnosed, according to the SCID for DSM-IV, with schizophrenia, schizoaffective disorder or schizophreniform psychosis.
- Patients must have good response to anti-psychotic treatment by achieving a rating of 2 or below in Clinical Global Impression Scale (CGI) Severity of illness; a rating of 4 or below in Improvement scale, and a rating of 3 or below in (conceptual disorganization, unusual thought content), a rating of 2 or below in (delusion, hallucinatory behavior) and a rating of 4 or below in (Suspiciousness) of Positive and Negative Syndrome Scale (PANSS) for at least 8 weeks
Exclusion Criteria:
- Female patients who are either pregnant or lactating.
- Patients previously on clozapine should be excluded from the study
- Significant medical illnesses including seizures.
- DSM-IV substance (alcohol or other drugs) abuse or dependence within the past 3 months.
- Judged clinically to be at serious suicidal risk.
- Treatment with an injectable depot neuroleptic within less than one of the patient's dosing intervals between depot neuroleptic injections prior to study entry.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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For patients in remission while on maintenance medication, the study investigates whether medication discontinuation can be reached in 12 months following a first episode illness.
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Sekundære resultatmål
Resultatmål |
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Predictors of relapse, and costs and benefits of maintenance therapy in terms of functioning, quality of life, side effects, carer's burden, negative symptoms and cognitive symptoms.
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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.
Generelle publikationer
- Hui CLM, Honer WG, Lee EHM, Chang WC, Chan SKW, Chen ESM, Pang EPF, Lui SSY, Chung DWS, Yeung WS, Ng RMK, Lo WTL, Jones PB, Sham P, Chen EYH. Long-term effects of discontinuation from antipsychotic maintenance following first-episode schizophrenia and related disorders: a 10 year follow-up of a randomised, double-blind trial. Lancet Psychiatry. 2018 May;5(5):432-442. doi: 10.1016/S2215-0366(18)30090-7. Epub 2018 Mar 15.
- Chen EY, Hui CL, Lam MM, Chiu CP, Law CW, Chung DW, Tso S, Pang EP, Chan KT, Wong YC, Mo FY, Chan KP, Yao TJ, Hung SF, Honer WG. Maintenance treatment with quetiapine versus discontinuation after one year of treatment in patients with remitted first episode psychosis: randomised controlled trial. BMJ. 2010 Aug 19;341:c4024. doi: 10.1136/bmj.c4024.
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. august 2003
Studieafslutning (Faktiske)
1. juni 2007
Datoer for studieregistrering
Først indsendt
2. juni 2006
Først indsendt, der opfyldte QC-kriterier
2. juni 2006
Først opslået (Skøn)
6. juni 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. februar 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. februar 2011
Sidst verificeret
1. juni 2008
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D1441C09906
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 .