- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01044914
Genes, Intermediate Phenotypes and Response to Quetiapine RX
12. maj 2016 opdateret af: Alessandro Bertolino, University of Bari
Use of Clinical and Intermediate Phenotypes to Assess Response to Quetiapine: the Role of Putative Causative Genes
Pharmacological treatment of schizophrenia is still characterized by a certain proportion of patients who are resistant to common antipsychotics.
Variability in individual response ranges from patients who experience complete or near complete symptom remission to a subset of patients who remain treatment-refractory despite extensive drug trials over years.
The investigators propose to take advantage of the simultaneous acquisition of clinical and of intermediate phenotypes to ascertain the possible contribution of SNPs within putative causative genes to response to treatment with quetiapine XR.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bari, Italien, 70124
- Clinica Psichiatrica - Azienda Ospedaliera Policlinico Bari
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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
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The study will be carried out in a hospital unit of the psychiatric assistance system.We will recruit 100 patients with schizophrenia with recent exacerbation of psychotic symptomatology.
Beskrivelse
Inclusion Criteria:
- Provision of written informed consent
- Diagnosis of schizophrenia using the Structured Clinical Interview for Diagnosis for the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition
- Male or female patients aged between 18 and 65 years
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin test at enrollment
- Able to understand and comply with the requirements of the study
- Patients with a cut off value for PANSS more than 75
Exclusion Criteria:
- Pregnancy or lactation
- Any DSM-IV Axis I disorder not defined in the inclusion criteria
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
- Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
- Administration of a depot antipsychotic injection within one dosing interval before randomization
- Patients treated with clozapine within 28 days before the enrollment
- Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence)
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
- Involvement in the planning and conduct of the study
- Previous enrollment or randomization of treatment in the present study
- Participation in another drug trial within 4 weeks prior to enrollment into this study or longer in accordance with local requirements
- A patient with Diabetes Mellitus
- An absolute neutrophil count of ¬1.5 x 109 per liter
- Pre-existing Organic Mental Disorder or Mental Retardation.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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The primary outcome measure will be the change from baseline in clinical symptoms assessed by PANSS scores measures based on BDNF genotype in schizophrenic patients after quetiapine XR treatment
Tidsramme: after 56 days of treatment
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after 56 days of treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. december 2009
Primær færdiggørelse (Faktiske)
1. oktober 2010
Studieafslutning (Faktiske)
1. oktober 2010
Datoer for studieregistrering
Først indsendt
7. januar 2010
Først indsendt, der opfyldte QC-kriterier
7. januar 2010
Først opslået (Skøn)
8. januar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. maj 2016
Sidst verificeret
1. maj 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2009-013028-21
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 .