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To detect the effect of second-generation antipsychotic drug on the neural activity.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risperidone then Placebo | Experimental | 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. |
|
| Placebo then Risperidone | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Repeatable Battery for the Assessment of Neuropsychological Status | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Simpson-Angus Extrapyramidal Side Effects Scale | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feedback-based Probabilistic Classification Task | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miklos Argyelan, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zucker-Hillside Hospital | Glen Oaks | New York | 11004 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21300943 | Background | Ho BC, Andreasen NC, Ziebell S, Pierson R, Magnotta V. Long-term antipsychotic treatment and brain volumes: a longitudinal study of first-episode schizophrenia. Arch Gen Psychiatry. 2011 Feb;68(2):128-37. doi: 10.1001/archgenpsychiatry.2010.199. |
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Subjects were immediately randomized to either Arm 1 or Arm 2.
Recruitment was done between 9/4/2013 and 9/19/2014 at the Department of Research at the Zucker Hillside Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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, on third day they did not receive anything. |
| FG001 | 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, on the third day they did not receive anything. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1 |
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| Day2 |
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| Day3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Risperidone |
| BG001 | Placebo Then Risperidone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Because right after enrollment pt inn placebo then risperidone arm was found to be pregnant and was ruled out from the study, no baseline information exist. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Repeatable Battery for the Assessment of Neuropsychological Status | 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 | Posted | Mean | Standard Deviation | RBANS T-Scale point difference | The change of RBANS scores between placebo and treatment conditions on two consecutive days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Risperidone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Miklos Argyelan | Northwell Health | 718-470-8175 | margyela@northwell.edu |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Other | We gave oral liquid without active risperidone (pt and provider were both double blinded) |
|
| 2 times on risperidone day and on placebo day |
| Before every MRI except the 2nd and 4th which will occur during the MRI (5 times - 3 consecutive days) |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
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
Risperidone
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | One subject exited study after enrollment due to pregnancy. | Count of Participants | Participants |
|
| Region of Enrollment | One subject exited study after enrollment due to pregnancy test came back positive. | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | 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. Risperidone |
| OG001 | 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 Risperidone |
|
|
| Secondary | Simpson-Angus Extrapyramidal Side Effects Scale | 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. | We analyzed the difference between patients who received drug versus placebo on the first day. 0 would mean no side effects after administration of risperidone or placebo. | Posted | Mean | Standard Deviation | units on a scale | 2 times on risperidone day and on placebo day |
|
|
|
| Other Pre-specified | Feedback-based Probabilistic Classification Task | 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. | We lumped individuals from both arms to four groups depending on the task and the medication status and calculated the percentage of correct responses. Due to computer problems 3 subjects' data were lost. | Posted | Mean | Standard Deviation | percentage of correct response | Before every MRI except the 2nd and 4th which will occur during the MRI (5 times - 3 consecutive days) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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 Risperidone | 0 | 4 | 0 | 4 |
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