Lurasidone Pediatric Bipolar Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar I Depression

In brief

A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression

Key facts

Study ID: NCT02046369
Run by: Sumitomo Pharma America, Inc.
People needed: 350
Starts: 2014-03-01
Expected to finish: 2016-10-01
Last updated by the study team: 2017-12-20

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' adherence to the study procedures must be obtained for subjects who are not emancipated. If emancipated, subjects must provide written informed consent. In accordance with Institutional Review Board (IRB) requirements, the subject will complete an informed assent prior to study participation.
Male or female subjects 10 to 17 years of age, inclusive with bipolar I disorder, most recent episode depressed, with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) and without psychotic features (diagnosed by DSM-V criteria, and confirmation of the bipolar I disorder diagnosis by an adequately trained clinician at the time of screening, by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children [K-SADS-PL]). Note: The current episode of major depression associated with bipolar I disorder must be confirmed by the investigator and noted in the source records.
Subject has a lifetime history of at least one manic episode. A reliable informant (eg, family member or caregiver) or medical records must be able to confirm this history.
Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration.
CDRS-R score ≥ 45 at screening and Baseline.
YMRS score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤ 2) at screening and Baseline.
Within 3rd to 97th percentile for gender specific BMI-for-age growth charts from the World Health Organization (WHO) growth charts
In good physical health on the basis of medical history, physical examination, and laboratory screening.
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.
In the judgment of the investigator, the subject is able to swallow the size and number of study drug tablets specified per protocol
Willing and able to adhere to protocol-specified meal requirements during dosing.
Subjects may have a lifetime diagnosis of ADHD. If a subject is taking psychostimulants for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the investigator and noted in the source records.

You may not qualify if…

Has an Axis I or Axis II (DSM-IV or any DSM-5) diagnosis other than bipolar I disorder that has been the primary focus of treatment within 3 months of screening.
Subject has been hospitalized for a bipolar manic or mixed episode within the 30 days prior to randomization.
Has a history or current diagnosis of intellectual disability, autism spectrum disorder, neuroleptic malignant syndrome, or any neurologic disorder, or severe head trauma.
Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C.
Any of the following:
Documented history of chromosomal disorder with developmental impairment (ie, trisomy chromosome 21; 22q11 deletion syndrome).
Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood - eg, Duchenne muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders. In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.
CDRS-R total score > 85 at screening or Baseline
Demonstrates a decrease (improvement) of ≥ 25% in the CDRS-R adjusted total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline.
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.
Lifetime history of electroconvulsive therapy (ECT).
Resistant to antipsychotic treatment based on at least two prior adequate trials (ie, adequate dose and duration) of an antipsychotic agent within the current episode of depression, or subject has a history of non-response to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode.
Clinically significant neurological, metabolic (including Type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.
Has a history of malignancy < 5 years prior to signing the informed consent.
Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study.
Clinically relevant abnormal laboratory values or abnormal vital sign values/findings.
A history or presence of abnormal ECG, which in the investigator's opinion is clinically significant. Abnormal screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read.
Presence or history (within the last year) of a medical or surgical condition (eg, gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
Clinically significant substance abuse disorder (with the exception of caffeine or tobacco) based on DSM-5 criteria within the last 6 months prior to screening.
Positive test results at screening or Baseline for:
Urine drugs of abuse (including amphetamines/methamphetamines, barbiturates, benzodiazepines, cocaine, opioids, phencyclidine, and cannabinoids). A positive test for amphetamines/methamphetamines, barbiturates, opioids, or benzodiazepines may not result in exclusion of subjects if the investigator determines that the positive test is as a result of taking prescription medicine(s) as prescribed. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the investigator will evaluate the subject's ability to abstain from prohibited substances during the study. If in the investigator's clinical judgment the subject will abstain, the subject may be enrolled after consultation with the Medical Monitor.
Pregnancy test.
Females who are pregnant, lactating, or likely to become pregnant during the study.
Participated in another interventional clinical trial or receiving an investigational product within 30 days prior to screening.
Donation of whole blood within 60 days prior to randomization.

Where it is running

ProScience Research Group — Culver City, California, United States
Hartford Hospital — Hartford, Connecticut, United States
Sarkis Clinical Trials - Parent — Gainesville, Florida, United States
APG Research, LLC — Orlando, Florida, United States
Atlanta Center for Medical Research — Atlanta, Georgia, United States
Attalla Consultants, LLC — Smyrna, Georgia, United States
Capstone Clinical Research, Inc. — Libertyville, Illinois, United States
Psychiatric Associates — Overland Park, Kansas, United States
Lake Charles Clinical Trials, LLC — Lake Charles, Louisiana, United States
Kennedy Krieger Institute — Baltimore, Maryland, United States
Neurobehavioral Medicine Group, PLLC — Bloomfield Hills, Michigan, United States
St. Charles Psychiatric Associates — Saint Charles, Missouri, United States
Jersey Shore University Medical Center — Neptune City, New Jersey, United States
North Shore/Long Island Jewish PRIME — Glen Oaks, New York, United States
Bioscience Research, LLC — Mount Kisco, New York, United States
Finger Lakes Clinical Research — Rochester, New York, United States
Richmond Behavioral Associates — Staten Island, New York, United States
University of Cincinnati Medical Center — Cincinnati, Ohio, United States
University Hospitals Case Medical Center — Cleveland, Ohio, United States
Cutting Edge Research of Enid — Oklahoma City, Oklahoma, United States
Research Strategies of Memphis, LLC — Memphis, Tennessee, United States
BioBehavioral Research of Austin — Austin, Texas, United States
Pillar Clinical Research, LLC — Dallas, Texas, United States
Family Psychiatry of The Woodlands, P.A. — The Woodlands, Texas, United States
Harmonex Neuroscience Research — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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