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Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers

30. marts 2018 opdateret af: Miklos Argyelan, MD, Northwell Health
To detect the effect of second-generation antipsychotic drug on the neural activity.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

To detect functional correlation changes in the brain with anti-psychotic drug administration as compared to placebo, and b.) to measure if these changes correlate with the plasma level of anti-psychotic, and c.) to evaluate if these changes correlate with drug induced symptoms and changes in cognitive function.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

11

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
        • 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

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Between 18 and 60 years of age
  • Subject is competent to provide informed consent

Exclusion Criteria:

  • Mini Mental Status Exam is less than 28
  • Past or current history of any psychotic illness in the subject or in first degree family members
  • Self report of illicit drug use (except marijuana) in the past. Use of marijuana during the last 3 month...
  • Any use of antipsychotic in the past.
  • Any neuro-anatomical lesions on previous brain imaging
  • Any use of D2 receptor blocking agent (such as antiemetics) in the last two weeks.
  • Any use of any psychotropic medications (SSRI, mood stabilizers, benzodiazepines, stimulants) in the last month.
  • MRI contraindications
  • Any cardiovascular or cerebrovascular diseases or conditions that predispose patients to hypotension (eg. dehydration, hypovolemia, antihypertensive medication)
  • Subjects with diabetes mellitus, metabolic syndrome, hepatic or renal impairment, seizure disorder and any neurological disorder
  • QTc interval longer than 450 ms for male and 470 ms for female
  • Subjects who used any medications in the last two weeks (to avoid any possible drug-drug interactions)
  • Pregnancy
  • Individuals who are illiterate and/or visually impaired

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Risperidone then Placebo
This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day.
Medicin: Risperidone
We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.
Andet: Placebo
We gave oral liquid without active risperidone (pt and provider were both double blinded)
Eksperimentel: Placebo then Risperidone
This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day
Medicin: Risperidone
We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.
Andet: Placebo
We gave oral liquid without active risperidone (pt and provider were both double blinded)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Repeatable Battery for the Assessment of Neuropsychological Status
Tidsramme: The change of RBANS scores between placebo and treatment conditions on two consecutive days

This will measure the subject's cognitive performance. RBANS is a well-characterized repeatable battery to measure a wide array of cognitive performance in different cognitive domains. We will use Total Score in RBANS: five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. More detailed information is available: Randolph C, Tierney MC, Mohr E, Chase TN (June 1998). "The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity". J Clin Exp Neuropsychol. 20 (3): 310-9. doi:10.1076/jcen.20.3.310.823. PMID 9845158.

Here we calculated the difference of T-scaled total RBANS score between risperidone day and placebo day in all participants
The change of RBANS scores between placebo and treatment conditions on two consecutive days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Simpson-Angus Extrapyramidal Side Effects Scale
Tidsramme: 2 times on risperidone day and on placebo day
The secondary outcome measures are the scores from side effect scales (Simpson-Angus Extrapyramidal Side Effects. It will measured in synchrony with Repeated Battery for the Assessment of Neuropsychological Status to explore if any of these measures would correlate with network changes in the brain. The Simpson-Angus scale is 0 if there is no extrapyramidal side effects, and is higher the worst the symptoms are.
2 times on risperidone day and on placebo day

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feedback-based Probabilistic Classification Task
Tidsramme: Before every MRI except the 2nd and 4th which will occur during the MRI (5 times - 3 consecutive days)
On each trial, participants will view one of four images and will be asked to guess whether it belongs to Category A or B. For each participant, the four images will be randomly assigned to be stimuli S1, S2, S3 and S4 (these are abstract visual stimuli denoted with numbers (stiumulus 1, stimulus 2, etc). A different set of similar images (S5-S8; S9-S12, etc) will be used for repeated testing. On any given trial, stimuli S1 and S3 will belong to Category A with 90% probability and to Category B with 10% probability, while stimuli S2 and S4 will belong to Category B with 90% probability and to Category A with 10% probability. Stimuli S1 and S2 will be used in the reward-learning task and S3 and S4 in punishment-learning task. Two stimuli per valence will be employed in order to balance category outcome frequencies, so that one stimulus in each task will be associated with each outcome.
Before every MRI except the 2nd and 4th which will occur during the MRI (5 times - 3 consecutive days)

Samarbejdspartnere og efterforskere

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

Sponsor

Northwell Health

Efterforskere

  • Ledende efterforsker: Miklos Argyelan, MD, Northwell Health

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

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. juli 2013

Primær færdiggørelse (Faktiske)

1. juli 2016

Studieafslutning (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først indsendt

12. august 2013

Først indsendt, der opfyldte QC-kriterier

26. august 2013

Først opslået (Skøn)

29. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. marts 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 13-036

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 .

Kliniske forsøg med Risperidone

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