- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00257075
A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder
13. januar 2011 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The Efficacy And Safety Of Flexible Dosage Ranges Of Risperidone Versus Placebo In The Treatment Of Manic Episodes Associated With Bipolar I Disorder.
The purpose of the study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo during 3 weeks of treatment of mania in patients with Bipolar I Disorder who are suffering a manic episode.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Antipsychotic agents have, for a long time, been used to alleviate the severe behavioral problems associated with manic episodes.
Risperidone, widely used in the treatment of schizophrenia, has been shown to be effective in the treatment of manic and mixed episodes associated with bipolar disorders.
This is a randomized, double-blind, placebo-controlled study to evaluate the effectiveness and safety of risperidone compared with placebo in the treatment of patients with bipolar disorder who are experiencing a manic episode.
Patients receive study medication (risperidone or placebo tablets) to be taken orally once a day at gradually increasing doses during the first week to achieve optimal effectiveness, while minimizing any intolerance to the drug.
By Day 4, the dose of risperidone is in the range of 1 to 6 mg/day, and treatment with risperidone or placebo tablets continues for 3 weeks.
The primary measure of effectiveness is the change in the Young Mania Rating Scale (YMRS) total score from baseline to the end of treatment.
Additional assessments of effectiveness include the Clinical Global Impression-Severity of Illness (CGI-S) scale; the Global Assessment Scale (GAS), which assesses the patient's level of functioning; and the Positive and Negative Syndrome Scale (PANSS), a scale for measuring psychotic symptoms.
Safety assessments include the incidence of adverse events throughout the study; measurement of vital signs (temperature, pulse, blood pressure) and evaluation of the presence and severity of extrapyramidal symptoms by the Extrapyramidal Symptom Rating Scale (ESRS) at specified intervals; and clinical laboratory tests (hematology, biochemistry, urinalysis) at the start and end of the study.
The study hypothesis is that daily treatment with risperidone is more effective than placebo, as measured by Young Mania Rating Scale scores, in the treatment of the manic phase of Bipolar I Disorder.
Risperidone tablets,1 mg (or placebo tablets) taken orally once daily in the evening; dose of 3 mg on Day 1; dose range of 2 - 4 mg on Day 2; dose range 1 - 5 mg on Day 3; dose range 1 - 6 mg on Days 4 - 21. Doses may be increased or decreased at investigator's discretion.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
267
Fase
- Fase 3
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
Beskrivelse
Inclusion Criteria:
- Patients with a diagnosis of Bipolar I Disorder, Most Recent Episode Manic, by the criteria in the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- voluntarily hospitalized at study initiation for the current manic episode
- history of at least one documented manic or mixed episode that required treatment prior to study initiation
- total score of >=20 on the Young Mania Rating Scale (YMRS) and total score of <=20 on the Montgomery Asberg Depression Rating Scale (MADRS) at start of the study
Exclusion Criteria:
- Patients who meet DSM-IV criteria for Schizoaffective Disorder or for rapid cycling
- with borderline or antisocial personality disorder
- history of substance dependence (excluding nicotine and caffeine) within the 3 months prior to study initiation
- with seizure disorder
- females who are pregnant or nursing, or those lacking adequate contraception.
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: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Change in Young Mania Rating Scale (YMRS) total score from baseline to the end of treatment.
|
Sekundære resultatmål
Resultatmål |
---|
Change from baseline to the end of treatment in Clinical Global Impression-Severity of Illness (CGI-S) scale, Global Assessment Scale (GAS), and Positive and Negative Syndrome Scale (PANSS) total score; incidence of adverse events throughout study.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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.
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 2000
Studieafslutning (Faktiske)
1. maj 2002
Datoer for studieregistrering
Først indsendt
18. november 2005
Først indsendt, der opfyldte QC-kriterier
18. november 2005
Først opslået (Skøn)
22. november 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. januar 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. januar 2011
Sidst verificeret
1. januar 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske processer
- Sygdomme i nervesystemet
- Neurologiske manifestationer
- Neuroadfærdsmæssige manifestationer
- Bipolære og relaterede lidelser
- Sygdom
- Maniodepressiv
- Mani
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninmidler
- Dopaminmidler
- Serotonin-antagonister
- Dopamin-antagonister
- Risperidon
Andre undersøgelses-id-numre
- CR006052
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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University of California, Los AngelesNational Institute of Mental Health (NIMH); Janssen Scientific Affairs,...AfsluttetSkizofreniForenede Stater
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Janssen Pharmaceutica N.V., BelgiumAfsluttetAdfærdsforstyrrelse | Oppositionel Defiant Disorder | Disruptiv adfærdsforstyrrelse
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