Evaluation of the Strategies of Switching Schizophrenia Patients to Aripiprazole From Other Antipsychotic Agents
16. maj 2012 opdateret af: National Taiwan University Hospital
Evaluation of the Strategies of Switching Schizophrenia Patients to Aripiprazole From Other Antipsychotic Agents: Combination of Pharmacogenomics and Therapeutic Drug Monitoring
The purpose of this study is to determine whether moderately ill Asian schizophrenic patients can be switched from their previous antipsychotic medication to aripiprazole with minimal adverse clinical consequences, and elucidate both pharmacokinetic and pharmacodynamic factors associated with clinical efficacy of aripiprazole.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Aripiprazole (commercial name abilify) is the first commercially available drug with dopamine partial agonist effects approved for the treatment of schizophrenia and bipolar disorder since 2002 in the U.S. It reduces negative symptoms of schizophrenia efficiently and has a markedly lower incidence of extrapyramidal symptoms and tardive dyskinesia. However, the process of switching other antipsychotic agents to aripiprazole can result in a re-emergence or worsening of psychosis, along with unpleasant side effects such as insomnia, nausea, vomiting, anxiety and agitation. On the basis of a prior study demonstrating the efficacy and safety of aripiprazole in Taiwan population, we hence propose to apply a combined use of pharmacogenomics and therapeutic drug monitoring in the evaluation of the strategies of switching stable schizophrenia patients to aripiprazole from other antipsychotic agents.
We will evaluate their cytochrome P450 background along with other potential candidate genes of schizophrenia. This 2-year proposal will examine the relative efficacy, safety and tolerability of two different strategies for switching stable inpatients/outpatients from prior antipsychotic monotherapy to aripiprazole 15 mg/day monotherapy using two different strategies:
- Fast tapering of the previous medication within 1 week after initiating aripiprazole for 2 weeks.
- Slow tapering of the previous medication within 4 weeks after initiating aripiprazole for 2 weeks.
A total of 200 stable schizophrenia patients will be randomized with open label to two strategies.
We expect to achieve the following results:
- Developing a protocol that has high probability of switching successfully schizophrenia patients to aripiprazole, which is effective in treatment refractory cases and has a markedly lower incidence of severe side effects, from other antipsychotics.
- Elucidate both pharmacokinetic and pharmacodynamic factors associated with clinical efficacy of aripiprazole.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
79
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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Taipei, Taiwan, 100
- Department of Psychiatry, National Taiwan University Hospital
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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:
- Men and non-lactating, non-pregnant women who are aged 18 to 65 years
- primary diagnosis of DSM-IV schizophrenia or schizoaffective disorder
- taking a stabilized dose of a single oral antipsychotic for at least 1 month prior to study entry
- cannot have been hospitalized for an exacerbation of schizophrenia or schizoaffective disorder for at least 2 months
Exclusion Criteria:
- having other psychiatric disorders
- hospitalizing for acute exacerbation of patients' condition within 2 months
- having taken a selective serotonin reuptake inhibitor (SSRI) within 4 weeks of screening
- a first episode of schizophrenia or schizoaffective disorder
- a clinically significant neurological abnormality other than tardive dyskinesia or EPS
- current diagnosis of psychoactive substance dependence or a historical drug or alcohol abuse within 1 month before the beginning of the study
- treatment with an investigational drug within 4 weeks prior to randomization
- requiring to take medication that inhibits the microsomal enzyme CYP2D6 or inhibits or acts as a substrate for CYP3A4
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: 1
fast tapering of the previous medication within 1 week after initiating aripiprazole for 2 weeks
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Aripiprazole will be given as a fixed does, 15 mg/day, orally throughout 8 weeks in the 2 arms.
Andre navne:
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Aktiv komparator: 2
slow tapering of the previous medication within 4 weeks after initiating aripiprazole for 2 weeks
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Aripiprazole will be given as a fixed does, 15 mg/day, orally throughout 8 weeks in the 2 arms.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Treatment efficacy was assessed using PNASS, Clinical Global Impression (CGI) Scale, and EPS rating scales
Tidsramme: on days 0, 7, 14, 28, 56
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on days 0, 7, 14, 28, 56
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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HPLC analysis Genotyping
Tidsramme: on days 0, 14, 56
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on days 0, 14, 56
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Tzung-Jeng Hwang, MD, Department of Psychiatry, National Taiwan University Hospital
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
- Ma CH, Chan HY, Hsieh MH, Liu CC, Liu CM, Hwu HG, Kuo CH, Chen WJ, Hwang TJ. Identifying dopamine supersensitivity through a randomized controlled study of switching to aripiprazole from other antipsychotic agents in patients with schizophrenia. Ther Adv Psychopharmacol. 2022 Jan 28;12:20451253211064396. doi: 10.1177/20451253211064396. eCollection 2022.
- Jen YW, Hwang TJ, Chan HY, Hsieh MH, Liu CC, Liu CM, Hwu HG, Kuo CH, Lin YT, Chien YL, Chen WJ. Abnormally low prolactin levels in schizophrenia patients after switching to aripiprazole in a randomized trial: a biomarker for rebound in psychotic symptoms? BMC Psychiatry. 2020 Nov 23;20(1):552. doi: 10.1186/s12888-020-02957-7.
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 2007
Primær færdiggørelse (Faktiske)
1. juni 2009
Studieafslutning (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først indsendt
15. oktober 2007
Først indsendt, der opfyldte QC-kriterier
15. oktober 2007
Først opslået (Skøn)
17. oktober 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. maj 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. maj 2012
Sidst verificeret
1. januar 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Skizofrenispektrum og andre psykotiske lidelser
- Skizofreni
- Psykotiske lidelser
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninmidler
- Antidepressive midler
- Dopaminagonister
- Dopaminmidler
- Serotonin 5-HT1-receptoragonister
- Serotoninreceptoragonister
- Serotonin 5-HT2-receptorantagonister
- Serotonin-antagonister
- Dopamin D2-receptorantagonister
- Dopamin-antagonister
- Aripiprazol
Andre undersøgelses-id-numre
- 200705030M
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 .
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