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Pediatric Open-Label Extension Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Sunovion
Information provided by (Responsible Party):
Sunovion Identifier:
First received: July 30, 2013
Last updated: July 6, 2016
Last verified: July 2016
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

Condition Intervention Phase
Bipolar Depression
Drug: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects

Resource links provided by NLM:

Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Number of treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation and serious AEs (SAEs) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in Laboratory tests [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in Tanner staging, and menstrual cyclicity (female subjects) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in Vital Signs [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
    Vital signs following 5 minutes of seated rest will consist of supine systolic and diastolic blood pressures, respiration rate, heart rate, and oral body temperature.

  • Change in Body weight and body mass index [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in Physical Examination [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
    The physical examination includes an assessment of general appearance and a review of systems (dermatologic, head, eyes, ears, nose, mouth/throat/neck, thyroid, lymph nodes, respiratory, cardiovascular, gastrointestinal, extremities, musculoskeletal, neurologic, and psychiatric systems).

  • Change in height (as measured by stadiometer) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Change in electrocardiogram [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
    All ECGs will be obtained in the supine position, after the subject has been resting supine for at least 10 minutes.

Secondary Outcome Measures:
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • CogState Computerized Cognitive Test Battery [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Clinical Global Impression-Severity (CGI-S) scale [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Clinician-rated Children's Global Assessment Scale (CGAS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist (ABC) [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Children's Yale-Brown Obsessive Compulsive Scales [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Caregiver Strain Questionnaire (CGSQ) [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Children's Depression Rating Scale, Revised (CDRS-R) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Young Mania Rating Scale (YMRS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Pediatric Anxiety Rating Scale (PARS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 295
Study Start Date: September 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Lurasidone 20, 40, 60, 80 mg, flexibly dosed, once daily
Drug: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed
Other Name: Latuda


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01914393

Contact: Medical Director 1-866-503-6351

  Show 99 Study Locations
Sponsors and Collaborators
Study Director: Lurasidone Medical Director, MD Sunovion
  More Information

Responsible Party: Sunovion Identifier: NCT01914393     History of Changes
Other Study ID Numbers: D1050302  2013-001694-24 
Study First Received: July 30, 2013
Last Updated: July 6, 2016
Health Authority: United States: Food and Drug Administration
Ukraine: Ministry of Health
Italy: The Italian Medicines Agency
Serbia: Medicines and Medical Devices Agency
Bulgaria: Bulgarian Drug Agency
Colombia: National Institutes of Health
China: Ministry of Health
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Philippines : Food and Drug Administration
Mexico: Ministry of Health

Keywords provided by Sunovion:

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on October 21, 2016