E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Extension study for the D1050301 Adolescent Schizophrenia study, the D1050325 Children and Adolescent autistic disorder and the D1050326 Children and Adolescent Bioplar I Depression |
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E.1.1.1 | Medical condition in easily understood language |
Subjects who completed participation in preceding studies with lurasidone will be eligible in this study. |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004936 |
E.1.2 | Term | Bipolar depression |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10039628 |
E.1.2 | Term | Schizophrenia and other psychotic disorders |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003808 |
E.1.2 | Term | Autistic disorder |
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 |
To evaluate the long-term safety, tolerability, and effectiveness of lurasidone (20, 40, 60 or 80 mg/day, flexibly dosed) in pediatric subjects who have completed a prior lurasidone study. |
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E.2.2 | Secondary objectives of the trial |
• Proportions of subjects with adverse events (AEs), discontinuations due to AEs, and serious AEs (SAEs). Subjects from D1050301: • Change in Positive and Negative Syndrome, general psychopathology, and excitability; in the Clinical Global Impression; in the Clinician-rated Children’s Global Assessment Scale; in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire. Subjects from D1050325: • Change in Aberrant Behavior;in the Clinical Global Impression – Severity; in Children's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders; in the Caregiver Strain Questionnaire. Subjects from D1050326: • Change in the Children's Depression Rating Scale, the Clinical Global Impression Bipolar Version ; in the Clinician-rated Children’s Global Assessment Scale; in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire; in anxiety symptoms as measured by the Pediatric Anxiety Rating Scale; in attention-deficit/hyperactivity |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects’ participation in the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. 2. Subject has completed Study D1050301 or 325 (Visit 9); OR Subject has completed Study D1050326 (Visit 8). 3. Subject is judged by the investigator to be appropriate for participation in a 104-week clinical trial in an outpatient setting involving open-label lurasidone treatment, and is able to comply with the protocol. 4. A reliable informant (eg, parent, legal guardian, or caregiver) must be available to accompany the subject at each visit. For subjects entering from Study D1050325, the reliable caregiver must also oversee the administration of the study drug throughout the study. 5. Females who participate in this study: • are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR- • practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR- • are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken. 6. Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken |
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E.4 | Principal exclusion criteria |
1. Subject is considered by the investigator to be at imminent risk of suicide.
2. Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator |
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E.5 End points |
E.5.1 | Primary end point(s) |
6.1. Safety Assessments All Subjects: • Treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation and serious AEs (SAEs); • Laboratory tests, vital signs, body weight and body mass index (BMI), waist circumference, physical examination, height (as measured by stadiometer), electrocardiogram (ECG), hormonal parameters; • Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS); • Tanner staging, and menstrual cyclicity (female subjects). For subjects continued from Study D1050301 and D1050326: • Columbia Suicide Severity Rating Scale (C-SSRS); • Composite Score of the CogState Computerized Cognitive Test Battery; • Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU). For subjects continued from Study D1050326: • Young Mania Rating Scale (YMRS) score. 6.2. Effectiveness Assessments For subjects continued from Study D1050301: • Positive and Negative Syndrome Scale (PANSS); • Clinical Global Impression-Severity (CGI-S) scale; • Clinician-rated Children’s Global Assessment Scale (CGAS); • Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q). For subjects continued from Study D1050325: • Aberrant Behavior Checklist (ABC); • Clinical Global Impression-Severity (CGI-S) scale; • Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for pervasive developmental disorders (PDDs); • Caregiver Strain Questionnaire (CGSQ). For subjects continued from Study D1050326: • Children's Depression Rating Scale, Revised (CDRS-R); • Clinical Global Impression Bipolar Version -Severity (CGI-BP-S) scale; Clinician-rated Children’s Global Assessment Scale (CGAS); • Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q); • Pediatric Anxiety Rating Scale (PARS); • Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) |
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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) |
see all listed under E.5.1 above |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
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 |
Croatia |
France |
Germany |
Hungary |
Korea, Republic of |
Malaysia |
Mexico |
Philippines |
Poland |
Puerto Rico |
Romania |
Russian Federation |
Serbia |
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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Visit 29E EOS/ET (Week 104) |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 15 |