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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001064 |
E.1.2 | Term | Acute schizophrenia |
E.1.2 | System Organ Class | 100000004873 |
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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 |
To evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in adolescent subjects with acute schizophrenia (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria) as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of lurasidone compared with placebo as measured by the change from Baseline in the Clinical Global Impression, Severity (CGI-S) at Week 6;
- To evaluate the efficacy of lurasidone compared with placebo as measured by the change from Baseline in PANSS positive, negative, general psychopathology, and excitability subscale scores at Week 6;
- To evaluate the efficacy of lurasidone compared with placebo in changes in quality of life as measured by the change from Baseline in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) at Week 6;
- To evaluate the efficacy of lurasidone compared with placebo in changes in global functioning as measured by the change from Baseline in the Clinician-rated Children’s Global Assessment Scale (CGAS) at Week 6;
- To evaluate the safety and tolerability of lurasidone at 40 mg/day and 80 mg/day. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female subjects 13 to 17 years of age, inclusive, with DSM-IV-TR Axis I primary diagnosis of schizophrenia and confirmation of the schizophrenia diagnosis by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children (K-SADS-PL). Positive and Negative Syndrome Scale (PANSS) total score ≥ 70 at screening and Baseline; CGI-S ≥ 4 at screening and Baseline. |
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E.4 | Principal exclusion criteria |
Has an Axis I or Axis II diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.; Has a history or current diagnosis of mental retardation, neuroleptic malignant syndrome, or any neurologic disorder, severe head trauma, or any unstable medical condition. PANSS total scores ≥ 120 at screening or Baseline. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Change from Baseline in Clinical Global Impression severity
(CGI-S) scale;
- Change from Baseline in PANSS positive, negative, general psychopathology, and excitability subscale scores;
- Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q);
- Change from Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS);
- Proportion of responders, where response is based on ≥ 20% improvement from Baseline in PANSS total score at Week 6.
- Proportion of remitters, defined as subjects who have score not exceeding 3 (mild severity) for items P1, P2, P3, N1, N4, N6, G5, and G9 of the PANSS at Week 6. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Bulgaria |
China |
Colombia |
Croatia |
France |
Germany |
Hungary |
Korea, Republic of |
Malaysia |
Mexico |
Philippines |
Poland |
Puerto Rico |
Romania |
Russian Federation |
Spain |
Ukraine |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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End of Study (EOS): Visit 9 Week 6
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |