Study in Adolescents With Schizophrenia or Bipolar Disorder
maanantai 8. joulukuuta 2014 päivittänyt: Eli Lilly and Company
A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents With Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia
Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar I disorder (manic or mixed episodes) or schizophrenia.
Tutkimuksen yleiskatsaus
Tila
Valmis
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
203
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Caguas, Puerto Rico, 00725
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Juan, Puerto Rico, 00927
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Poznan, Puola, 60-792
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Torun, Puola, 87-100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wroclaw, Puola, 54-235
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lipetsk, Venäjän federaatio, 399313
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Moscow, Venäjän federaatio, 115522
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Petrozavodsk, Venäjän federaatio, 185001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saint Petersburg, Venäjän federaatio, 192019
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saratov, Venäjän federaatio, 410060
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Lauderhill, Florida, Yhdysvallat, 33319
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Michigan
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Bloomfield Hills, Michigan, Yhdysvallat, 48302
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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St Louis, Missouri, Yhdysvallat, 63128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Bellevue, Washington, Yhdysvallat, 98007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
13 vuotta - 17 vuotta (Lapsi)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- Participants must have a diagnosis of bipolar I disorder and display an acute manic or mixed episode (with or without psychotic features) or a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR)and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL).
- Participants with a diagnosis of schizophrenia must obtain a Brief Psychiatric Rating Scale for Children (BPRS-C) total score >30, with a minimum score of 3 on at least one of the following items at both screening and randomization - hallucinations, delusions, peculiar fantasies.
- Participants with a diagnosis of bipolar I disorder must have a Young Mania Rating Scale (YMRS) total score greater than or equal to 15 at both screening and randomization.
- Has given assent (when applicable); and has a parent or authorized legal representative who has given informed consent, is reliable, has a level of understanding sufficient to permit participant to perform all tests and examinations required by the protocol, and understands the nature of the study.
Exclusion Criteria:
- History of mental retardation, current comorbid autism, or current comorbid Pervasive Developmental Disorder.
- Have DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days prior to randomization.
- Been judged clinically to be at any suicidal risk.
- History of allergic reaction or hypersensitivity to olanzapine.
- Receiving current pharmaceutical treatment for weight management or are participating in a structured behavioral diet and/or exercise weight loss program.
- Other antipsychotics, mood stabilizers, or anticonvulsants (for mood stabilization) used for the primary study conditions (bipolar I disorder or schizophrenia)
- Have acute, serious, or unstable medical conditions
- Have any illness such that death is anticipated within 1 year or intensive care unit hospitalization for the illness is anticipated within 12 months (365 days).
- Have had one or more seizures without a clear and resolved etiology.
- Baseline alanine aminotransferase (ALT) values greater than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory or aspartate aminotransferase (AST) values greater than or equal to 2 times the ULN or total bilirubin values greater than or equal to 1.5 times the ULN at screening.
- Have leukopenia or history of leukopenia without a clear and resolved etiology or known history of agranulocytosis (absolute neutrophil count <500 cubic millimeter [mm^3], <0.5 GI/L, or <0.5 10E^3/microliters [μL]) during the participant's lifetime.
- Prolactin level of >200 nanograms per milliliter (ng/mL) [>200 micrograms per liter (ug/L), or >4228 milli-International unit per liter (mIU/L)] at screening.
- Have QTc (Bazett's) >450 milliseconds (males) or >460 milliseconds (females) at screening.
- Previously been randomized in this study and/or participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to screening.
- Currently prescribed olanzapine for greater than or equal to 5 days within 1 month (30 days) prior to screening.
- Are investigator site personnel directly affiliated with this study and/or their immediate families OR are employed by or representatives of Lilly.
- Pregnant or nursing.
- Have received treatment within the last 30 days with an investigational new drug that has not received regulatory approval for any indication at the time of study entry.
- Treatment with clozapine within 14 days prior to randomization.
- Participants who have used olanzapine (that is, oral olanzapine, intramuscular [IM] olanzapine, or olanzapine orally disintegrating tablets) and have had treatment withdrawn due to clinically significant and/or intolerable adverse effects, or who have exhibited a lack of efficacy/response to treatment to olanzapine including treatment resistance.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Olanzapine/standard behavioral weight intervention
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2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks
Muut nimet:
One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only.
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Kokeellinen: Olanzapine/intense behavioral weight intervention
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2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks
Muut nimet:
Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits.
Participants also provided with simple tools to help enable healthy eating and exercise habits.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants
Aikaikkuna: Baseline, 52 weeks
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Baseline, 52 weeks
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months
Aikaikkuna: Baseline, 52 weeks
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Baseline, 52 weeks
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Time to Event for 7%, 15%, and 25% Weight Gain for All Participants
Aikaikkuna: Baseline up to 52 weeks
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Kaplan-Meier methodology used to estimate time to event.
Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set).
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Baseline up to 52 weeks
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Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder
Aikaikkuna: Baseline, 52 weeks
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The YMRS is an 11-item scale that measures the severity of manic episodes.
Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe).
The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe).
The YMRS total score ranges from 0 (symptom not present) to 60 (symptom extremely severe).
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Baseline, 52 weeks
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Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants
Aikaikkuna: 52 weeks
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The Clinical Global Impression of Improvement (CGI-I) is used by the clinician to record the improvement of illness at the time of assessment.
The score ranges from 1 (very much improved) to 7 (very much worse).
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52 weeks
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Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants
Aikaikkuna: Baseline, 52 weeks
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Baseline, 52 weeks
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Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants
Aikaikkuna: Baseline, 52 weeks
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The CGI-S is used by the clinician to record the severity of illness at the time of assessment.
The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill.
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Baseline, 52 weeks
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Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia
Aikaikkuna: Baseline, 52 weeks
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The BPRS-C characterizes psychopathology.
A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126.
A decrease in score indicates a reduction in psychopathology.
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Baseline, 52 weeks
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Tiistai 1. syyskuuta 2009
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 1. toukokuuta 2013
Opintojen valmistuminen (Todellinen)
Keskiviikko 1. toukokuuta 2013
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 15. syyskuuta 2009
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 21. syyskuuta 2009
Ensimmäinen Lähetetty (Arvio)
Tiistai 22. syyskuuta 2009
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Keskiviikko 17. joulukuuta 2014
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 8. joulukuuta 2014
Viimeksi vahvistettu
Maanantai 1. joulukuuta 2014
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Mielenterveyshäiriöt
- Skitsofreniaspektri ja muut psykoottiset häiriöt
- Skitsofrenia
- Huumeiden fysiologiset vaikutukset
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Keskushermostoa lamaavat aineet
- Autonomiset agentit
- Ääreishermoston aineet
- Antiemeetit
- Ruoansulatuskanavan aineet
- Antipsykoottiset aineet
- Rauhoittavat aineet
- Psykotrooppiset lääkkeet
- Serotoniinin sisäänoton estäjät
- Neurotransmitterien sisäänoton estäjät
- Kalvon kuljetusmodulaattorit
- Serotoniinin aineet
- Olantsapiini
Muut tutkimustunnusnumerot
- 12117
- F1D-MC-HGMX (Muu tunniste: Eli Lilly and Company)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .