E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039629 |
E.1.2 | Term | Schizophrenia childhood |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study was to evaluate the long-term (2-year) safety and tolerability of paliperidone ER in at least 100 adolescent subjects (12 to 17 years of age, inclusive) with schizophrenia. |
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E.2.2 | Secondary objectives of the trial |
Exploratory secondary objectives of this study were to:
• Assess the effect of paliperidone ER on the long-term symptoms of schizophrenia as measured by the changes in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores;
• Assess the global improvement in severity of illness associated with treatment with paliperidone ER as measured by the Clinical Global Impression-Severity (CGI-S) scale;
• Assess the benefits in psychological, social, and school functioning associated with treatment with paliperidone ER as measured by the Children’s Global Assessment Scale (CGAS);
• Assess the changes in multiple domains of cognitive functioning associated with treatment with paliperidone ER as assessed by the Measurements and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) cognition assessment battery;
• Assess the effect on sleep associated with treatment with paliperidone ER as measured by the sleep Visual Analog Scale (VAS). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Must be male or female, between 12 and 17 years of age, inclusive. Subject must meet the DSM-IV criteria for schizophrenia for at least one year. Parents or legal guardians must sign an informed consent and subjects must sign an assent. Subjects must be otherwise physically healthy and have no active or clinically significant medical problems. Subjects must weigh >/=29 kg. Female subjects were capable of pregnancy must take appropriate contraceptive measures or agree to abstinence throughout the duration of the study. Subjects must not be a danger to themselves or others. |
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E.4 | Principal exclusion criteria |
Subjects who meet DSM-IV criteria for a major axis I disorder, mild, moderate, or severe mental retardation, a known or suspected history of substance dependence in the three months preceding screening, or at increased risk for the occurrence of QT prolongation are excluded. Subjects with a known or suspected history of seizure disorder, NMS, TD, IDDM, active malignancy, or a significant or unstable medical illness are excluded. Subjects with a significant abnormality in clinical laboratory tests or ECG are also excluded. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Effect of paliperidone on prolactin on growth and maturation. Effects on lipid levels, body weight and height, waist circumference, ECGs, fasting glucose, insulin, Tanner staging, EPS, sedation, monitoring of psychiatric adverse events (suicide related phenomena, homicidal ideation, depressed mood and worsening of psychosis) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
According to a pre-defined time and events schedule over approximate 108 week study duration |
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E.5.2 | Secondary end point(s) |
Assess the effect of paliperidone ER on long-term symptoms of schizophrenia as measured by the changes in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores.
Assess the effect of paliperidone ER on the long-term symptoms of schizophrenia as measured by the changes in the PANSS negative symptom scale based on Marder factors.
Assess the global improvement in severity of illness associated with treatment with paliperidone ER as measured by the Clinical Global Impression - Severity (CGI-S) scale.
Assess the benefits in psychological, social, and school functioning associated with treatment with paliperidone ER as measured by the Children’'s Global Assessment Scale (CGAS).
Assess the changes in multiple domains of cognitive functioning associated with treatment with paliperidone ER as assessed by the modified Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment battery.
Assess the effect on sleep associated with treatment with paliperidone ER as measured by the sleep Visual Analog Scale (VAS). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
According to a pre-defined time and events schedule over the 108 week study duration |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
India |
Korea, Democratic People's Republic of |
Russian Federation |
Ukraine |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |