Phase 3
Completed N=702
Pediatric Open-Label Extension Study
Source: ClinicalTrials.gov NCT01914393 ↗Enrolled (actual)
702
Serious AEs
11.1%
Results posted
Dec 2019
Primary outcomePrimary: Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) — 214; 106; 252; 572 Participants
◆ Published Evidence
Emerging
11citations · ~2 / year
Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression.
Summary
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326
Linked Publications
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Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) |
214; 106; 252; 572; 28; 13 | — |
| SECONDARY Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score |
76.0; -11.9; -15.6; -18.4 | — |
| SECONDARY Change From Baseline in PANSS Positive Subscale Score |
17.9; -3.9; -5.1; -5.4 | — |
| SECONDARY Change From Baseline in PANSS Negative Subscale Score |
20.5; -2.6; -3.4; -4.3 | — |
| SECONDARY Change From Baseline in PANSS General Psychopathology Subscale Score |
37.5; -5.4; -7.2; -8.7 | — |
| SECONDARY Change From Baseline in PANSS Excitability Subscale Score |
9.0; -1.3; -1.7; -2.1 | — |
| SECONDARY Change From Baseline in the Clinical Global Impression -Severity Score |
4.0; -0.87; -1.10; -1.31 | — |
| SECONDARY Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score |
55.0; 10.94; 14.28; 17.85 | — |
| SECONDARY Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score |
59.52; 8.16; 11.37; 14.75 | — |
| SECONDARY Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score |
19.0; -2.1; -2.9; -4.2 | — |
| SECONDARY Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score |
10.3; -0.7; -1.1; -1.1 | — |
| SECONDARY Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score |
6.1; -0.9; -0.9; -1.1 | — |
| SECONDARY Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score |
24.1; -3.8; -4.3; -5.6 | — |
| SECONDARY Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score |
5.2; -0.7; -0.7; -0.5 | — |
| SECONDARY Change From Baseline in Clinical Global Impression (CGI) - Severity Score |
3.9; -0.43; -0.71; -0.78 | — |
| SECONDARY Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS) |
10.2; -2.2; -2.3; -3.2 | — |
| SECONDARY Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score |
7.95; -0.48; -0.60; -0.63 | — |
| SECONDARY Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score |
39.2; -9.9; -13.4; -16.4 | — |
| SECONDARY Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score |
3.2; -1.10; -1.36; -1.61 | — |
| SECONDARY Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score |
61.1; 11.17; 14.67; 18.96 | — |
| SECONDARY Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score |
8.0; -2.7; -3.2; -4.9 | — |
| SECONDARY Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score |
9.4; -2.2; -2.4; -3.3 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Subject has completed Study D1050301 (Visit 9) OR
- Subject has completed Study D1050325 (Visit 9) OR
- Subject has completed Study D1050326 (Visit 8)
- 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.
- 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
- 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.
- 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.
Exclusion Criteria
- Subject is considered by the investigator to be at imminent risk of suicide.
- 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.
Data sourced from ClinicalTrials.gov (NCT01914393) and the linked publication. 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.