Multicenterundersøgelse af Lumateperone til behandling af bipolar depression hos pædiatriske patienter
En randomiseret, dobbeltblind, placebokontrolleret, multicenterundersøgelse til evaluering af Lumateperons effektivitet og sikkerhed til behandling af svære depressive episoder (MDE'er) forbundet med bipolar I eller bipolar II lidelse (bipolar depression) hos pædiatriske patienter i alderen 10 til 17 år Flere år
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
The study will be conducted in 3 phases:
- Screening Period (up to 2 weeks) during which patient eligibility will be assessed
- Double-blind Treatment Period (6 weeks) during which all patients will be randomized to receive lumateperone or placebo in 1:1 ratio.
- Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately one week after the last dose of study drug.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Barranquilla, Colombia, 080020
- Rekruttering
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
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Bello, Colombia, 051053
- Rekruttering
- Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO
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Bogotá, Colombia, 111166
- Afsluttet
- Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
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Pereira, Colombia, 660002
- Rekruttering
- Psynapsis Salud Mental S.A.
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Alabama
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Dothan, Alabama, Forenede Stater, 36303
- Rekruttering
- Harmonex Neuroscience Research
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72204
- Rekruttering
- Pillar Clinical Research, LLC
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California
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Anaheim, California, Forenede Stater, 92805
- Rekruttering
- Advanced Research Center, Inc
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Redlands, California, Forenede Stater, 92373
- Rekruttering
- Inland Psychiatric Medical Group Inc
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Sacramento, California, Forenede Stater, 95817
- Rekruttering
- UC Davis Health System
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San Diego, California, Forenede Stater, 92103
- Afsluttet
- University of California San Diego Medical Center
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West Covina, California, Forenede Stater, 91790
- Rekruttering
- Next Level Clinical Trials, LLC
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80910
- Afsluttet
- MCB Clinical Research Centers LLC
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Florida
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Fort Myers, Florida, Forenede Stater, 33901
- Suspenderet
- Royal Palm Clinical Research
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Hialeah, Florida, Forenede Stater, 33012
- Afsluttet
- United Research Institute
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Homestead, Florida, Forenede Stater, 33033
- Suspenderet
- Advanced Research Institute of Miami
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Miami, Florida, Forenede Stater, 33176
- Rekruttering
- Links Clinical Trials
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Miami, Florida, Forenede Stater, 33125
- Afsluttet
- Columbus Clinical Services LLC
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Miami, Florida, Forenede Stater, 33122
- Suspenderet
- Vital Care Research
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Miami, Florida, Forenede Stater, 33130
- Rekruttering
- Care Research Center Inc
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Miami, Florida, Forenede Stater, 33165
- Suspenderet
- AP Medical Research
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Miami, Florida, Forenede Stater, 33134
- Rekruttering
- HealthMed Clinical Center Inc
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Miami, Florida, Forenede Stater, 33144
- Afsluttet
- Ocean Blue Medical Research Center Inc.
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Miami, Florida, Forenede Stater, 33166
- Rekruttering
- Envision Trials LLC
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Miami, Florida, Forenede Stater, 33186
- Afsluttet
- SouthGen Clinical Research LLC
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Miami, Florida, Forenede Stater, 33173
- Afsluttet
- GTL Medical and Research Group
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Miami Gardens, Florida, Forenede Stater, 33056
- Rekruttering
- New Med Research Inc
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Miami Gardens, Florida, Forenede Stater, 33169
- Rekruttering
- The Angel Medical Research Corporation
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Miami Lakes, Florida, Forenede Stater, 33014
- Rekruttering
- Riveldi Biomedical Research
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Orlando, Florida, Forenede Stater, 32803
- Rekruttering
- APG Research LLC
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West Palm Beach, Florida, Forenede Stater, 33407
- Rekruttering
- Health Synergy Clinical Research
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Georgia
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Atlanta, Georgia, Forenede Stater, 30030
- Rekruttering
- CenExeli Research LLC
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Atlanta, Georgia, Forenede Stater, 30318
- Afsluttet
- Advanced Discovery Research
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Lawrenceville, Georgia, Forenede Stater, 30046
- Afsluttet
- Salveo Integrative Health Inc
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Savannah, Georgia, Forenede Stater, 31405
- Rekruttering
- CenExeli Research LLC 1
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Rekruttering
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Elgin, Illinois, Forenede Stater, 60123
- Rekruttering
- Revive Research Institute
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Afsluttet
- Indiana University
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Maryland
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Baltimore, Maryland, Forenede Stater, 21229
- Afsluttet
- MTP Psychiatry LLC
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Michigan
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Bloomfield Hills, Michigan, Forenede Stater, 48302
- Rekruttering
- Neurobehavioral Medicine Group
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Missouri
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Saint Charles, Missouri, Forenede Stater, 63304
- Rekruttering
- Midwest Research Group
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St Louis, Missouri, Forenede Stater, 63110
- Afsluttet
- Washington University School of Medicine Child and Adolescent Psychiatry Clinic
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68526
- Rekruttering
- Alivation Research LLC
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New York
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New York, New York, Forenede Stater, 10016
- Rekruttering
- NYU Child Study Center
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Ohio
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Avon Lake, Ohio, Forenede Stater, 44012
- Afsluttet
- Haidar Almhana Nieding
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Cincinnati, Ohio, Forenede Stater, 45219
- Rekruttering
- University of Cincinnati Medical Center
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Garfield Heights, Ohio, Forenede Stater, 44125
- Rekruttering
- Charak Center for Health and Wellness
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Westlake, Ohio, Forenede Stater, 44145
- Afsluttet
- Westlake America Clinic
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73116
- Afsluttet
- Cutting Edge Research Group
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Oklahoma City, Oklahoma, Forenede Stater, 73116
- Rekruttering
- Sooner Clinical Research
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Rekruttering
- SP Research, PLLC (dba Rivus Wellness & Research Institute)
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Texas
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Austin, Texas, Forenede Stater, 78701
- Rekruttering
- The University of Texas at Austin
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Austin, Texas, Forenede Stater, 78759
- Afsluttet
- BioBehavioral Research of Austin PC
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Beaumont, Texas, Forenede Stater, 77701
- Rekruttering
- REX Clinical Trials LLC
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Flower Mound, Texas, Forenede Stater, 76028
- Afsluttet
- North Pointe Psychiatry
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Houston, Texas, Forenede Stater, 77090
- Afsluttet
- Red Oak Psychiatry Associates
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Houston, Texas, Forenede Stater, 77089
- Rekruttering
- Kaleidoscope Clinical Research
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Richmond, Texas, Forenede Stater, 77407
- Rekruttering
- Perceptive Pharma Research
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Virginia
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Richmond, Virginia, Forenede Stater, 23220
- Rekruttering
- Virginia Commonwealth University
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Washington
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Bellevue, Washington, Forenede Stater, 98007
- Rekruttering
- Northwest Clinical Research Center
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Everett, Washington, Forenede Stater, 98201
- Rekruttering
- Core Clinical Research
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Ahmedabad, Indien, 380008
- Suspenderet
- Ratandeep Surgical Hospital And Endoscopy Clinic
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Chhatrapati Sambhajinagar, Indien, 431005
- Suspenderet
- Society for Psychiatric Update and Research Shanti Nursing Home
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Nashik, Indien, 422005
- Suspenderet
- Chopda Medicare & Research Centre
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Varanasi, Indien, 221005
- Suspenderet
- Deva Institute of Healthcare And Research Pvt Ltd
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Belgrade, Serbien, 11000
- Aktiv, ikke rekrutterende
- Clinic of Neurology and Psychiatry for Children and Youth
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Belgrade, Serbien, 11000
- Aktiv, ikke rekrutterende
- Institute of Mental Health Serbia
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Niš, Serbien, 18000
- Aktiv, ikke rekrutterende
- University Clinical Center NIS
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Novi Sad, Serbien, 21000
- Suspenderet
- Clinical Center of Vojvodina
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
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Able to provide consent as follows:
- The Legally Authorized Representative (LAR) must provide written, informed consent.
- The patient must provide written assent;
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Male or female patients 10 to 17 years of age, inclusive;
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Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
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Subject has a lifetime history of at least one manic or hypomanic episode.
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Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
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CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
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Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤ 2) at Screening and Baseline.
Exclusion Criteria:
-
Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:
- Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications 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.
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Intellectual disability based on Investigator opinion and DSM-5 criteria
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Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
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Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;
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In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
- At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
- At Screening or Baseline, scores > 3 on Item 13 (suicidal ideation) on the CDRS-R; or
- The patient is considered to be an imminent danger to him/herself or others.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Lumateperone
Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years. |
Lumateperone administered orally, once daily. |
|
Placebo komparator: Placebo
Matching placebo |
Matching placebo administered orally, once daily. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Children's Depression Rating Scale-Revised (CDRS-R)
Tidsramme: Week 6
|
The Children's Depression Rating Scale-Revised is an observer-rated, 17-item semi-structured scale for pediatric patients. The scale comprises cognitive, somatic, affective, and psychomotor symptoms of depression. Items are rated for severity on a 7-point scale (1 to 7) for 14 items and on a 5-point scale (1 to 5) for three items. Total scores range from 7 to 113. |
Week 6
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Global Impression Scale-Severity (CGI-S)
Tidsramme: Week 6
|
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
Week 6
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- ITI-007-421
- ITI-007-421 (Anden identifikator: Janssen Research & Development, LLC)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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