Multicenterstudie av Lumateperone för behandling av bipolär depression hos pediatriska patienter
En randomiserad, dubbelblind, placebokontrollerad, multicenterstudie för att utvärdera effektiviteten och säkerheten av Lumateperone för behandling av allvarliga depressiva episoder (MDE) associerade med bipolär I eller Bipolär II sjukdom (bipolär depression) hos pediatriska patienter i åldern 10 till 17 år 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).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studieorter
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Barranquilla, Colombia, 080020
- Rekrytering
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
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Bello, Colombia, 051053
- Rekrytering
- Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO
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Bogotá, Colombia, 111166
- Avslutad
- Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
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Pereira, Colombia, 660002
- Rekrytering
- Psynapsis Salud Mental S.A.
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Alabama
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Dothan, Alabama, Förenta staterna, 36303
- Rekrytering
- Harmonex Neuroscience Research
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72204
- Rekrytering
- Pillar Clinical Research, LLC
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California
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Anaheim, California, Förenta staterna, 92805
- Rekrytering
- Advanced Research Center, Inc
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Redlands, California, Förenta staterna, 92373
- Rekrytering
- Inland Psychiatric Medical Group Inc
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Sacramento, California, Förenta staterna, 95817
- Rekrytering
- UC Davis Health System
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San Diego, California, Förenta staterna, 92103
- Avslutad
- University of California San Diego Medical Center
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West Covina, California, Förenta staterna, 91790
- Rekrytering
- Next Level Clinical Trials, LLC
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80910
- Avslutad
- MCB Clinical Research Centers LLC
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Florida
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Fort Myers, Florida, Förenta staterna, 33901
- Upphängd
- Royal Palm Clinical Research
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Hialeah, Florida, Förenta staterna, 33012
- Avslutad
- United Research Institute
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Homestead, Florida, Förenta staterna, 33033
- Upphängd
- Advanced Research Institute of Miami
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Miami, Florida, Förenta staterna, 33176
- Rekrytering
- Links Clinical Trials
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Miami, Florida, Förenta staterna, 33125
- Avslutad
- Columbus Clinical Services LLC
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Miami, Florida, Förenta staterna, 33122
- Upphängd
- Vital Care Research
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Miami, Florida, Förenta staterna, 33130
- Rekrytering
- Care Research Center Inc
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Miami, Florida, Förenta staterna, 33165
- Upphängd
- AP Medical Research
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Miami, Florida, Förenta staterna, 33134
- Rekrytering
- HealthMed Clinical Center Inc
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Miami, Florida, Förenta staterna, 33144
- Avslutad
- Ocean Blue Medical Research Center Inc.
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Miami, Florida, Förenta staterna, 33166
- Rekrytering
- Envision Trials LLC
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Miami, Florida, Förenta staterna, 33186
- Avslutad
- SouthGen Clinical Research LLC
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Miami, Florida, Förenta staterna, 33173
- Avslutad
- GTL Medical and Research Group
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Miami Gardens, Florida, Förenta staterna, 33056
- Rekrytering
- New Med Research Inc
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Miami Gardens, Florida, Förenta staterna, 33169
- Rekrytering
- The Angel Medical Research Corporation
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Miami Lakes, Florida, Förenta staterna, 33014
- Rekrytering
- Riveldi Biomedical Research
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Orlando, Florida, Förenta staterna, 32803
- Rekrytering
- APG Research LLC
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West Palm Beach, Florida, Förenta staterna, 33407
- Rekrytering
- Health Synergy Clinical Research
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Georgia
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Atlanta, Georgia, Förenta staterna, 30030
- Rekrytering
- CenExeli Research LLC
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Atlanta, Georgia, Förenta staterna, 30318
- Avslutad
- Advanced Discovery Research
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Lawrenceville, Georgia, Förenta staterna, 30046
- Avslutad
- Salveo Integrative Health Inc
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Savannah, Georgia, Förenta staterna, 31405
- Rekrytering
- CenExeli Research LLC 1
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Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Rekrytering
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Elgin, Illinois, Förenta staterna, 60123
- Rekrytering
- Revive Research Institute
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- Avslutad
- Indiana University
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Maryland
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Baltimore, Maryland, Förenta staterna, 21229
- Avslutad
- MTP Psychiatry LLC
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Michigan
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Bloomfield Hills, Michigan, Förenta staterna, 48302
- Rekrytering
- Neurobehavioral Medicine Group
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Missouri
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Saint Charles, Missouri, Förenta staterna, 63304
- Rekrytering
- Midwest Research Group
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St Louis, Missouri, Förenta staterna, 63110
- Avslutad
- Washington University School of Medicine Child and Adolescent Psychiatry Clinic
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Nebraska
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Lincoln, Nebraska, Förenta staterna, 68526
- Rekrytering
- Alivation Research LLC
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New York
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New York, New York, Förenta staterna, 10016
- Rekrytering
- NYU Child Study Center
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Ohio
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Avon Lake, Ohio, Förenta staterna, 44012
- Avslutad
- Haidar Almhana Nieding
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Cincinnati, Ohio, Förenta staterna, 45219
- Rekrytering
- University of Cincinnati Medical Center
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Garfield Heights, Ohio, Förenta staterna, 44125
- Rekrytering
- Charak Center for Health and Wellness
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Westlake, Ohio, Förenta staterna, 44145
- Avslutad
- Westlake America Clinic
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73116
- Avslutad
- Cutting Edge Research Group
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Oklahoma City, Oklahoma, Förenta staterna, 73116
- Rekrytering
- Sooner Clinical Research
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Oklahoma City, Oklahoma, Förenta staterna, 73112
- Rekrytering
- SP Research, PLLC (dba Rivus Wellness & Research Institute)
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Texas
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Austin, Texas, Förenta staterna, 78701
- Rekrytering
- The University of Texas at Austin
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Austin, Texas, Förenta staterna, 78759
- Avslutad
- BioBehavioral Research of Austin PC
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Beaumont, Texas, Förenta staterna, 77701
- Rekrytering
- REX Clinical Trials LLC
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Flower Mound, Texas, Förenta staterna, 76028
- Avslutad
- North Pointe Psychiatry
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Houston, Texas, Förenta staterna, 77090
- Avslutad
- Red Oak Psychiatry Associates
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Houston, Texas, Förenta staterna, 77089
- Rekrytering
- Kaleidoscope Clinical Research
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Richmond, Texas, Förenta staterna, 77407
- Rekrytering
- Perceptive Pharma Research
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Virginia
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Richmond, Virginia, Förenta staterna, 23220
- Rekrytering
- Virginia Commonwealth University
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Washington
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Bellevue, Washington, Förenta staterna, 98007
- Rekrytering
- Northwest Clinical Research Center
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Everett, Washington, Förenta staterna, 98201
- Rekrytering
- Core Clinical Research
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Ahmedabad, Indien, 380008
- Upphängd
- Ratandeep Surgical Hospital And Endoscopy Clinic
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Chhatrapati Sambhajinagar, Indien, 431005
- Upphängd
- Society for Psychiatric Update and Research Shanti Nursing Home
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Nashik, Indien, 422005
- Upphängd
- Chopda Medicare & Research Centre
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Varanasi, Indien, 221005
- Upphängd
- Deva Institute of Healthcare And Research Pvt Ltd
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Belgrade, Serbien, 11000
- Aktiv, inte rekryterande
- Clinic of Neurology and Psychiatry for Children and Youth
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Belgrade, Serbien, 11000
- Aktiv, inte rekryterande
- Institute of Mental Health Serbia
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Niš, Serbien, 18000
- Aktiv, inte rekryterande
- University Clinical Center NIS
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Novi Sad, Serbien, 21000
- Upphängd
- Clinical Center of Vojvodina
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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-jämförare: Placebo
Matching placebo |
Matching placebo administered orally, once daily. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Children's Depression Rating Scale-Revised (CDRS-R)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical Global Impression Scale-Severity (CGI-S)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ITI-007-421
- ITI-007-421 (Annan identifierare: Janssen Research & Development, LLC)
Läkemedels- och apparatinformation, studiedokument
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