Trial · NCT01284959
Different Safety Profile of Risperidone and Paliperidone Extended-release
NCT01284959, Phase 4, Completed, Chonbuk National University Hospital; results first posted 2012-10-23
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Different Safety Profile of Risperidone and Paliperidone Extended-release. Trials, record NCT01284959. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01284959
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Different Safety Profile of Risperidone and Paliperidone Extended-release
- NCT number
- NCT01284959
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 34 participants, actual
- Lead sponsor
- Chonbuk National University Hospital
- Conditions
- Schizophrenia
- Interventions
- risperidone, paliperidone ER, placebo
- First posted
- 2011-01-27
- Last updated
- 2012-10-23
- Results first posted
- 2012-10-23
- Limitations and caveats
The sample size was small, which presents higher risk of a type II error. The time of assessment after administering placebo or risperidone was noon to 2 PM, which may have contributed to the increased reports of sedation
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | baseline and 2hr after third medication | SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) In NIDSS, the average of number 1 to 5 is blunted affect, the average of number 16 to 20 is avolition, the average of number 6 to 15 is cognition, the average of all score is total. Minimum of NIDSS(avolition, blunted affect, cognition, total) is -3, maximum is +3.(subscale score and total) '+' is better outcome, '-' is worse outcome. Minimum of SANS-Global score for alogia and blunted affect is 0, Maximum of SANS-Global score for alogia and blunted affect is 5 The higher number is worse outcome. The zeros are measured and Calcuated value This outcome measure is reporting a change between baseline and 2hr after third medication. |
| Secondary | Assessment of Adverse Events by Objective Rating Scales and Self Report Scales | baseline and 2hr after third medication | DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed), and other types of feelings (happy-sad, antagonistic-amicable, interested-bored, withdrawn-gregarious) Minimum of VAS(Mental sedation score,Physical sedation score,Total score) is 0, Maximum is 10. VAS-total score is average of all subscale scores. Minimum of DIEPSS is 0, Maximum is 4. The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 2hr after third medication. |
| Secondary | Assessment of Adverse Events by Objective Rating Scales and Self Report Scales | baseline and 50hr after third medication | DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed), and other types of feelings (happy-sad, antagonistic-amicable, interested-bored, withdrawn-gregarious) Minimum of VAS is 0, Maximum is 10 Minimum of DIEPSS is 0, Maximum is 4 The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication. |
| Secondary | Assessment of Cognitive Functioning-1 | baseline and 50hr after third medication | CNT(Computerized Neuro-Cognitive Function Test System); The tests included a word fluency test. All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications. Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome. Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome. Minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome. Minimum of Word-fluency test is 0 and no maximum value, the higher number is better outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication. |
| Secondary | Symptoms Assessment by Objective Rating Scales | baseline and 50hr after third medication | SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) Minimum of NIDSS is -3, maximum of NIDSS is +3. '+' is better outcome, '-' is worse outcome. Minimum of SNAS-Global score is 0, Maximum of SNAS-Global score is 5 The higher number is worse outcome. The zeros are measured and Calcuated value. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication. |
| Secondary | Assessment of Cognitive Functioning-2 | baseline and 50hr after third medication | CNT(Computerized Neuro-Cognitive Function Test System); The tests included the Stroop test, Trail-Making Test B (TMT B). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications Minimum of Stroop test is 0, no maximum limit, the higher number is worse outcome. Minimum of Trail making test B is 0 and no maximum limit, the higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication. |
| Secondary | Assessment of Cognitive Functioning-3 | baseline and 50hr after third medication | CNT(Computerized Neuro-Cognitive Function Test System); The tests included Wisconsin Card-Sorting Test (WCST). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications. Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome. Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome. Minimum of Wisconsin card sorting test-Trials to complete first category trials is 0, Maximum is 128 and minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after th |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | baseline and 2hr after third medication | units on a scale | MEAN | |
| SECONDARY | Assessment of Adverse Events by Objective Rating Scales and Self Report Scales | baseline and 2hr after third medication | units on a scale | MEAN | |
| SECONDARY | Assessment of Adverse Events by Objective Rating Scales and Self Report Scales | baseline and 50hr after third medication | units on a scale | MEAN | |
| SECONDARY | Assessment of Cognitive Functioning-1 | baseline and 50hr after third medication | scores on a scale | MEAN | |
| SECONDARY | Symptoms Assessment by Objective Rating Scales | baseline and 50hr after third medication | units on a scale | MEAN | |
| SECONDARY | Assessment of Cognitive Functioning-2 | baseline and 50hr after third medication | milliseconds | MEAN | |
| SECONDARY | Assessment of Cognitive Functioning-3 | baseline and 50hr after third medication | trials | MEAN |
Source ClinicalTrials.gov
Results by group99
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | Risperidone | NIDSS-Avolition | -1.30 | Standard Deviation 1.22 | units on a scale |
| Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | Placebo | NIDSS-Avolition | -0.28 | Standard Deviation 0.64 | units on a scale |
| Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | Paliperidone ER | NIDSS-Avolition | -0.66 | Standard Deviation 0.53 | units on a scale |
| Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | Risperidone | NIDSS-Blunted Affect | -0.70 | Standard Deviation 0.74 | units on a scale |
| Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | Placebo | NIDSS-Blunted Affect | 0.02 | Standard Deviation 0.35 | units on a scale |
| Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | Paliperidone ER | NIDSS-Blunted Affect | -0.24 | Standard Deviation 0.64 | units on a scale |
| Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | Risperidone | NIDSS-Cognition | -0.54 | Standard Deviation 0.53 | units on a scale |
| Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | Placebo | NIDSS-Cognition | 0.02 | Standard Deviation 0.26 | units on a scale |
| Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | Paliperidone ER | NIDSS-Cognition | -0.38 | Standard Deviation 0.39 | units on a scale |
| Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales | Risperidone | NIDSS-Total | -0.77 | Standard Deviation 0.70 | units on a scale |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Risperidone | 11 | |
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | STARTED | Paliperidone ER | 11 | |
| Overall Study | COMPLETED | Risperidone | 10 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | COMPLETED | Paliperidone ER | 10 | |
| Overall Study | NOT COMPLETED | Risperidone | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Paliperidone ER | 1 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | sedation | Gastrointestinal disorders | Risperidone | 5 | 11 | 5 |
| other | sedation | Gastrointestinal disorders | Placebo | 2 | 12 | 2 |
| other | sedation | Gastrointestinal disorders | Paliperidone ER | 0 | 11 | 0 |
| other | abdominal discomfort | Gastrointestinal disorders | Risperidone | 2 | 11 | 2 |
| other | abdominal discomfort | Gastrointestinal disorders | Placebo | 1 | 12 | 1 |
| other | abdominal discomfort | Gastrointestinal disorders | Paliperidone ER | 0 | 11 | 0 |
| other | dizziness | Nervous system disorders | Risperidone | 2 | 11 | 2 |
| other | dizziness | Nervous system disorders | Placebo | 0 | 12 | 0 |
| other | dizziness | Nervous system disorders | Paliperidone ER | 0 | 11 | 0 |
| serious | Abdominal discomfort(vomiting) | Gastrointestinal disorders | Risperidone | 1 | 11 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Risperidone | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Paliperidone ER | ||
| Total, other adverse events | Risperidone | 5 | 11 |
| Total, other adverse events | Placebo | 2 | 12 |
| Total, other adverse events | Paliperidone ER | 0 | 11 |
| Total, serious adverse events | Risperidone | 2 | 11 |
| Total, serious adverse events | Placebo | 0 | 12 |
| Total, serious adverse events | Paliperidone ER | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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