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Aripiprazole Treatment of the Prodrome

24. september 2009 opdateret af: Northwell Health

Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness

The RAP Program is conducting a research study of the antipsychotic medication Aripiprazole. This drug has been approved for treating symptoms associated with schizophrenia and is associated with fewer side effects. This study will explore how well Aripiprazole treats symptoms of early-onset psychotic disorders as well as symptoms that may indicate risk for such disorders, including unusual thoughts, suspiciousness, perceptual abnormalities, social isolation, and sudden changes in functioning.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Medicin: aripiprazol

Detaljeret beskrivelse

During the 12-week study, eligible patients are seen 7-9 times by research raters and psychiatrists. These visits include side effect monitoring, scheduled medication increases, and ratings designed to measure subtle improvement of symptoms. Monthly blood and urine samples are collected for safety and substance abuse monitoring, and neuropsychological testing is conducted at the first and last appointments. Participants are compensated for their participation and receive medication and study-related visits at no cost during the trial. Depending on their level of response to the medication, participants may also be eligible for a 3-month extension phase.

Undersøgelsestype

Interventionel

Tilmelding

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- New York
  - Glen Oaks, New York, Forenede Stater, 11004
    - RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital

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

13 år til 22 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

You are between the ages of 13 and 22.
You are English-speaking.
You have a diagnosed psychotic disorder, including: schizophrenia, schizophreniform disorder, schizoaffective disorder, or other psychotic disorder
OR -
You are experiencing one or more pre-psychotic symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
You meet additional RAP criteria assessed during screening and interview.

Exclusion Criteria:

You have a diagnosis of bipolar disorder or major depression with psychotic features.
You have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
You have past or current substance dependence.
You are currently taking Aripiprazole.
You have taken Aripiprazole in the past.
You are currently taking and responding well to another medication.

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: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Score on attenuated positive symptom scale at 12 weeks
Score on attenuated negative symptom scale at 12 weeks
Score on adverse events rating scale at 12 weeks

Sekundære resultatmål

Resultatmål
Score on social functioning scale at 12 weeks
Score on academic functioning scale at 12 weeks
Score on cognitive measures at 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Northwell Health

Samarbejdspartnere

Bristol-Myers Squibb

Efterforskere

Ledende efterforsker: Barbara Cornblatt, PhD, LIJMC

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.

Hjælpsomme links

RAP Program Homepage

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. januar 2004

Studieafslutning (Faktiske)

1. maj 2006

Datoer for studieregistrering

Først indsendt

9. september 2005

Først indsendt, der opfyldte QC-kriterier