Lurasidone Pediatric Bipolar Study



Status:Completed
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:10 - 17
Updated:12/22/2017
Start Date:March 2014
End Date:October 2016

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A Randomized, 6-Week, Double-blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Bipolar I Depression

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

This is a randomized, parallel, double-blind, placebo-controlled study designed to evaluate
the efficacy and safety of flexibly dosed lurasidone (20 - 80 mg/day) for 6 weeks compared
with placebo in children and adolescent subjects with depression associated with Bipolar I
Disorder (bipolar depression).

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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:

1. 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.

2. 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.

- Known history or presence of clinically significant intolerance to any antipsychotic
medications including but not limited to angioedema, serotonin or neuroleptic
malignant syndromes.

- Clinically relevant history of drug hypersensitivity to lurasidone or any components
in the formulation.

- Use of concomitant medications that consistently prolong the QT/QTc interval within 28
days prior to randomization.

- Received depot neuroleptics unless the last injection was at least 1 month or 1
treatment cycle prior to screening, whichever is longer.

- Received treatment with antidepressants, atomoxetine or alpha 2 agonists (eg,
guanfacine) within 3 days prior to randomization, fluoxetine hydrochloride within 21
days of randomization, monoamine oxidase (MAO) inhibitor within 28 days of
randomization, or clozapine within 120 days of randomization.

- Use of all psychotropic medications prior to randomization with the exception of those
medications explicitly permitted within 3 days prior to randomization (7 days prior to
randomization for aripiprazole).

- Has a prolactin concentration ≥ 100 ng/mL at screening, or has a history of pituitary
adenoma.

- At screening or Baseline the subject answers "yes" to "Suicidal Ideation" Items 4 or 5
on the C-SSRS or has a score of 7 on item 13, Suicidal Ideation, on the CDRS-R.

- Subject is considered by the investigator to be at imminent risk of suicide or injury
to self, others, or property during the study. Subject has a history of one or more
serious suicide attempts (based on the investigator's judgment) in the 3 months prior
to screening. Subjects determined to be at risk of suicide or injury, as assessed by
the investigator at screening, will be referred for further psychiatric evaluation.

- Adhering to a special diet for the 28 days prior to drug administration (eg, liquid,
protein, raw food diet).

- Subject is planning to move during the study, is chronically homeless, or is unable to
attend all planned study visits. The Medical Monitor will be consulted for individual
cases, as needed.

- Subject with newly diagnosed Type 2 diabetes during screening or subject is on
injectable medication for the treatment of Type 2 diabetes. A subject with Type 2
diabetes is eligible for study inclusion if considered clinically stable, which is
defined as:

- Random (non-fasting) screening glucose is < 200 mg/dl (11.1 mmol/L); and If ≥ 200
mg/dL (11.1 mmol/L) must be retested in a fasted state. Retested fasted value
cannot be ≥ 126 mg/dL.

- HbA1c ≤ 6.5%; and

- If a subject is currently being treated with oral anti-diabetic medication(s), the
dose must have been stable for at least 4 weeks prior to screening. Such medication
may be adjusted or discontinued during the study, as clinically indicated.

- Subject has required hospitalization for diabetes or related complications in the past
12 months.

- The use of concomitant medications that are potent inducers or inhibitors of the
cytochrome P450 (CYP) 3A4 enzyme system during the trial (from signing informed
consent until follow-up).

- Clinically significant orthostatic hypotension (ie, a drop in systolic blood pressure
of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 4
minutes of standing up).
We found this trial at
31
sites
707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Principal Investigator: Robert Findling, MD
Phone: 443-923-7620
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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Cincinnati, OH
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Austin, Texas 78759
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Bloomfield Hills, Michigan 48302
Principal Investigator: Sanjeev Venkataraman, MD
Phone: 248-290-5400
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Bothell, Washington 98011
Principal Investigator: Syed Mustafa, MD
Phone: 425-949-5779
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Vishal Madaan, MD
Phone: 434-243-6950
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Cleveland, Ohio 44194
Principal Investigator: Nora McNamara, MD
Phone: 216-844-5295
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Clinton, Utah 84015
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Culver City, California 90230
Principal Investigator: Marina Bussel, MD
Phone: 424-227-8127
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Dallas, Texas 75243
Principal Investigator: Scott Bartley, MD
Phone: 214-388-6455
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Dothan, Alabama 36303
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Gainesville, Florida 32607
Principal Investigator: Elias Sarkis, MD
Phone: 352-333-0094
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Glen Oaks, New York 11004
Principal Investigator: Vivian Kafantaris, MD
Phone: 718-470-3503
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
Principal Investigator: Salma Malik, MD
Phone: 860-545-7087
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Lake Charles, Louisiana 70601
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Libertyville, Illinois 60048
Principal Investigator: Michael Greenbaum, MD
Phone: 847-549-7214
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Memphis, Tennessee 38119
Principal Investigator: Anita Varma, MD
Phone: 901-685-8890
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Mount Kisco, New York 10549
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Neptune, New Jersey 07754
Principal Investigator: Ramon Solhkhah, MD
Phone: 732-643-4402
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Oklahoma City, Oklahoma 73116
Principal Investigator: Willis Holloway, MD
Phone: 405-603-8068
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Orem, Utah 84058
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Orlando, Florida 32803
Principal Investigator: Morteza Nadjafi, MD
Phone: 407-423-7149
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Overland Park, Kansas 66211
Principal Investigator: William Murphy, MD
Phone: 913-438-8221
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Petersburg, Virginia 23805
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Rochester, New York 14618
Principal Investigator: Sarah Atkinson, MD
Phone: 585-241-9670
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Ruse,
Principal Investigator: Bilyana Mechkunova, MD
Phone: +359878435022
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4801 Weldon Spring Parkway
Saint Charles, Missouri 63301
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Smyrna, Georgia 30080
Principal Investigator: Ashraf Attalla, MD
Phone: 770-319-8025
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Staten Island, New York 10312
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The Woodlands, Texas 77381
Principal Investigator: Marshall Lucas, MD
Phone: 281-367-1015
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