Phase 3
Completed N=400
Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
Schizophrenia · Schizophrenic Disorders · Psychotic disorders · Dementia Praecox
Source: ClinicalTrials.gov NCT00488319 ↗
Enrolled (actual)
400
Serious AEs
14.8%
Results posted
Jan 2014
Primary outcomePrimary: The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability — 32; 88; 221; 341 Number of Participants
Summary
The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability |
32; 88; 221; 341; 24; 61 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward |
-18.9; -12.6; -22.4; -19.1 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward |
-5.1; -3.4; -7.0; -5.7; -4.3; -3.8 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward |
-1.0; -1.0; -1.0; -1.0 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint in the Children's Global Assessment Scale (CGAS) - Last Observation Carried Forward |
11.3; 8.7; 15.6; 13.1 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward |
0.2; 0.1; 0.3; 0.2; 0.2; 0.4 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward |
1.9; 1.5; 0.1; 0.8 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward |
0.9; 0.8; 0.8; 0.8 | — |
| SECONDARY Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward |
0; 0.6; 1.7; 1.3 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward |
29.0; 3.5; 8.2; 7.2 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward |
-0.5; -0.3; 0.3; 0.0 | — |
| SECONDARY Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward |
3.4; 4.1; 5.6; 4.9 | — |
| SECONDARY Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward |
1.8; -2.3; 1.5; 0.0 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward |
0.0; 3.6; 6.2; 4.7 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward |
0.3; 0.2; 0.5; 0.4 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward |
0.2; 0.1; 0.2; 0.2 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward |
0.2; 0.7; 0.5 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward |
4.3; 4.6; 7.0; 5.9 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward |
8.2; 2.7; 9.8; 7.4 | — |
| SECONDARY Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward |
-7.4; -5.1; -3.9; -4.6 | — |
Eligibility Criteria
Inclusion Criteria
- Meets the DSM-IV criteria for schizophrenia, otherwise physically healthy
- Weight >=63.9 pounds (29 kg)
- Must not be a danger to self or others and must have family support available to be maintained as outpatients
- Responsible adult must be available to accompany the patient to the investigational site at each visit.
Exclusion Criteria
- Meets the DSM-IV criteria for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance-induced psychotic disorder
- mild, moderate, or severe mental retardation
- History of substance dependence (including alcohol, but excluding nicotine and caffeine) according to the DSM-IV criteria in the 3 months before screening
- pregnancy (for females)
- History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death in association with the use of drugs that prolong the QTc interval.
Data sourced from ClinicalTrials.gov (NCT00488319). 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. Informational only — not medical advice.