- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01931059
Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New York
-
Glen Oaks, New York, Förenta staterna, 11004
- Zucker-Hillside Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.
We gave oral liquid without active risperidone (pt and provider were both double blinded)
|
Experimentell: 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
|
We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.
We gave oral liquid without active risperidone (pt and provider were both double blinded)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Repeatable Battery for the Assessment of Neuropsychological Status
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Simpson-Angus Extrapyramidal Side Effects Scale
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Feedback-based Probabilistic Classification Task
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Miklos Argyelan, MD, Northwell Health
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 13-036
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