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Bipolar I DepressionPhase 3IlluminateNCT02046369

Lurasidone Pediatric Bipolar Study

A Phase 3 study testing Lurasidone in people with Bipolar I Depression, run by Sumitomo Pharma America, Inc. at 66 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Bipolar I Depression
What is being tested?
Lurasidone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
66 sitesin 11 countries
Study dates
Mar 2014to Oct 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
Show all 43Show fewer
  • 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.
  • 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).

Trial locations and contacts

66 sites in 11 countries.

66 sites in 11 countries

United States30 sites

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • BioBehavioral Research of Austin

    Austin, Texas, 78759

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21205

  • Neurobehavioral Medicine Group, PLLC

    Bloomfield Hills, Michigan, 48302

  • Pacific Institute Of Medical Sciences

    Bothell, Washington, 98011

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219-0516

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Ericksen Research & Development, LLC

    Clinton, Utah, 84015

  • ProScience Research Group

    Culver City, California, 90230

  • Pillar Clinical Research, LLC

    Dallas, Texas, 75228

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303

  • Sarkis Clinical Trials - Parent

    Gainesville, Florida, 32607

  • North Shore/Long Island Jewish PRIME

    Glen Oaks, New York, 11004

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Lake Charles Clinical Trials, LLC

    Lake Charles, Louisiana, 70629

  • Capstone Clinical Research, Inc.

    Libertyville, Illinois, 60048

  • Research Strategies of Memphis, LLC

    Memphis, Tennessee, 38119

  • Bioscience Research, LLC

    Mount Kisco, New York, 10549

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Cutting Edge Research of Enid

    Oklahoma City, Oklahoma, 73116

  • Aspen Clinical Research

    Orem, Utah, 84058

  • APG Research, LLC

    Orlando, Florida, 32803

  • Psychiatric Associates

    Overland Park, Kansas, 66211

  • Clinical Research Partners, LLC

    Petersburg, Virginia, 23805

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • St. Charles Psychiatric Associates

    Saint Charles, Missouri, 63301

  • Attalla Consultants, LLC

    Smyrna, Georgia, 30080

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Family Psychiatry of The Woodlands, P.A.

    The Woodlands, Texas, 77381

Other trials in United States

Ukraine9 sites

  • RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

    Ivano-Frankivsk, 76014

  • SI Institute of Neurology, Psychiatry and Narcology of NAMSU

    Kharkiv, 61068

  • SI Institute of Children and Adolescents Healthcare of NAMSU

    Kharkiv, 61153

  • CI Kherson Regional Psychiatric Hospital of Kherson RC

    Kherson, 73488

  • CI Lviv Regional Clinical Psychiatric Hospital

    Lviv, 79021

  • CI Odesa Regional Medical Center of Mental Health

    Odesa, 65006

  • O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy

    Poltava, 36006

  • Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU

    Ternopil, 46020

  • Chair of Psychiatry and Narcology, Vinnytsia National Medical University, O.I. Yushchenko Regional Psychoneurological Hospital

    Vinnytsia, 21005

Other trials in Ukraine

South Korea6 sites

  • Chonnam National University Hospital

    Gwangju, Jeollanam-do, 501-757

  • Inha University Hospital

    Incheon, 400-711

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 561-712

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Seoul National University Hospital

    Seoul, 110774

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

Other trials in South Korea

Mexico5 sites

  • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

    Culiacán, 80020

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000

  • Accelerium S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000

  • Instituto de Informacion de Investigacion en Salud Mental

    Monterrey, 64710

  • Consultorio Especializado Psiquiatría Infantil y Adolescentes

    San Luis Potosí City, 78200

Other trials in Mexico

Bulgaria3 sites

  • MHC - Ruse, EOOD

    Rousse, 7003

  • MHAT-Targovishte, AD

    Targovishte, 7700

  • DCC "Mladost M" - Varna, OOD

    Varna, 9020

Other trials in Bulgaria

Philippines3 sites

  • West Visayas State University Medical Center

    Iloilo City, 5000

  • National Center for Mental Health

    Mandaluyong, 1553

  • Veterans Memorial Medical Center

    Quezon City, 1101

Other trials in Philippines

Poland3 sites

  • NZOZ Poradnia Zdrowia Psychicznego

    Kobierzyce, 55-040

  • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

    Torun, 87-100

  • Instytut Psychiatrii i Neurologii

    Warsaw, 02-957

Other trials in Poland

Colombia2 sites

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA

    Barranquilla

  • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

    Bogotá, 00000

Other trials in Colombia

France2 sites

  • CHU Nantes - Hôpital Mère-Enfant

    Nantes, 44093

  • Hôpitaux Pédiatriques de Nice CHU-Lenval

    Nice, Alpes Maritimes, 06200

Other trials in France

Hungary2 sites

  • Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

    Budapest, 1021

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula, 5700

Other trials in Hungary

Puerto Rico1 site

  • INSPIRA Clinical Research

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: 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

Read the detailed description

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).

Being tested
Lurasidone, Placebo
Keywords
Lurasidone, Latuda, Bipolar Depression
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LurasidoneDrug

    Also called Latuda

    Lurasidone flexibly dosed 20-80 mg once daily

  • PlaceboDrug

    Placebo Comparator once daily

Study groups in NCT02046369
Study groupRoleWhat they receive
LuradisoneExperimentalLuradisone 20- 80 mg administered once daily
Receives: Drug: Lurasidone
PlaceboPlacebo comparatorPlacebo administered once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline

    CDRS-R total score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.

    The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness.

    The primary efficacy endpoint will be assessed between the placebo and treatment group.

    Measured: baseline, Week 6

Secondary outcomes (5)

  1. Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.

    PARS score: changes from baseline over time - mixed model for repeated measures-LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The PARS is a clinician-rated instrument for assessing over time the severity of anxiety symptoms associated with common DSM-IV anxiety disorders in children ages 6-17 years. The PARS is administered separately to the subject and to the caregiver. The instrument has 2 sections. The first section includes a 50-item symptom checklist, which the clinician rates as present or absent during the past week. The second section is comprised of 7 severity impairment items reflecting the severity/impairment of all symptoms endorsed in Section 1 of the PARS (during the past week). Each question is answered on a 0-5 Likert scale (0 for none, and 1-5 for minimal to extreme) with alternative responses of 8=Not Applicable and 9=Does Not Know. The PAR total score over all 7 questions ranges in value from 0 to 35.

    Measured: baseline and week 6

  2. Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.

    PQ-LES-Q percentage maximum possible score: changes from baseline over time - mixed model for repeated measures

    LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures

    Measured: baseline

  3. Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score as Compared to Placebo.

    CGAS Score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures

    Measured: baseline and week 6

  4. Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Score as Compared to Placebo.

    ADHD-RS total score: changes from baseline over time -ANCOVA-LS Mean and SE for change from baseline are based on ANCOVA. The Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:% Max = 100 × (Raw Score - Minimum Score) / (Maximum Score - Minimum Score),where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.

    Measured: baseline and week 6

  5. Change From Baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) Depression Score

    Change from baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) depression score changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The CGI-BP-S is a three-question clinician-rated assessment of the subject's current illness state (depression, mania, and overall) using a 7-point scale (1(normal, not ill) to 7 (very severely ill)) for each question, where a higher score is associated with greater illness severity.

    Measured: baseline and week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02046369
Sponsor's protocol ID
D1050326
Other IDs
2013-004903-37
Acronym
Illuminate
Status last verified
Nov 2017
First submitted
23 Jan 2014
Last updated
20 Dec 2017
Data monitoring committee
Yes

Publications

  • DelBello MP, Goldman R, Phillips D, Deng L, Cucchiaro J, Loebel A. Efficacy and Safety of Lurasidone in Children and Adolescents With Bipolar I Depression: A Double-Blind, Placebo-Controlled Study. J Am Acad Child Adolesc Psychiatry. 2017 Dec;56(12):1015-1025. doi: 10.1016/j.jaac.2017.10.006. Epub 2017 Oct 13.

    PubMed 29173735

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lurasidone in people with Bipolar I Depression, run by Sumitomo Pharma America, Inc. at 66 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Ukraine, South Korea, Mexico, Bulgaria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline (time frame: baseline, Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02046369, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.

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