Phase 4
N=34
Different Safety Profile of Risperidone and Paliperidone Extended-release
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01284959 ↗Enrolled (actual)
34
Serious AEs
5.9%
Results posted
Oct 2012
Primary outcome: Primary: Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales — -1.30; -0.28; -0.66; -0.70 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- risperidone (Drug); paliperidone ER (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chonbuk National University Hospital
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales |
-1.30; -0.28; -0.66; -0.70; 0.02; -0.24 | — |
| SECONDARY Assessment of Adverse Events by Objective Rating Scales and Self Report Scales |
6.15; 3.74; 3.42; 6.53; 4.21; 3.60 | — |
| SECONDARY Assessment of Adverse Events by Objective Rating Scales and Self Report Scales |
6.15; 3.74; 3.42; 6.53; 4.21; 3.60 | — |
| SECONDARY Assessment of Cognitive Functioning-1 |
22.22; 25.42; 23.50; 22.56; 26.00; 23.60 | — |
| SECONDARY Symptoms Assessment by Objective Rating Scales |
-0.85; -0.37; 0.14; -0.70; -0.27; 0.04 | — |
| SECONDARY Assessment of Cognitive Functioning-2 |
15.40; 13.09; 12.68; 21.84; 17.53; 18.31 | — |
| SECONDARY Assessment of Cognitive Functioning-3 |
6.00; 6.00; 6.00; 14.11; 13.08; 10.10 | — |
Summary
The main objective of this study was to assess subjective experiences related to secondary negative symptoms and cognitive performance in healthy volunteers in response to multiple doses of paliperidone ER and risperidone in a double-blind, placebo-controlled trial. Adverse events caused by these drugs were also evaluated.
Eligibility Criteria
Inclusion Criteria
- Aged 18-38 years and meet no DSM-IV diagnostic criteria as assessed by using the Structured Clinical Interview for DSM-IV, research version
Exclusion Criteria
Anyone who:
- Participated in other clinical trials within 30 days from the start of this clinical trial or is currently participating in one
- Has progressive disease or in unstable medical condition unfit for the trial
- Has been diagnosed in psychiatric terms in the past, depends on psychotropic substance, or has overdosed or depended on the substance or alcohol (except for coffee or tobacco) within 1 month from the trial start
- Is suicidal or highly probable of suicides; OR
- Has test results considered clinically meaningful
Data sourced from ClinicalTrials.gov (NCT01284959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.