Study in Adolescents With Schizophrenia or Bipolar Disorder
8. prosince 2014 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
203
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Poznan, Polsko, 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, Polsko, 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, Polsko, 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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Caguas, Portoriko, 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, Portoriko, 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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Lipetsk, Ruská Federace, 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, Ruská Federace, 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, Ruská Federace, 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, Ruská Federace, 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, Ruská Federace, 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, Spojené státy, 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, Spojené státy, 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, Spojené státy, 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, Spojené státy, 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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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
13 let až 17 let (Dítě)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Olanzapine/standard behavioral weight intervention
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2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks
Ostatní jména:
One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only.
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Experimentální: Olanzapine/intense behavioral weight intervention
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2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks
Ostatní jména:
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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants
Časové okno: Baseline, 52 weeks
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Baseline, 52 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2009
Primární dokončení (Aktuální)
1. května 2013
Dokončení studie (Aktuální)
1. května 2013
Termíny zápisu do studia
První předloženo
15. září 2009
První předloženo, které splnilo kritéria kontroly kvality
21. září 2009
První zveřejněno (Odhad)
22. září 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
17. prosince 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. prosince 2014
Naposledy ověřeno
1. prosince 2014
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Duševní poruchy
- Schizofrenní spektrum a jiné psychotické poruchy
- Schizofrenie
- Fyziologické účinky léků
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Depresiva centrálního nervového systému
- Autonomní agenti
- Agenti periferního nervového systému
- Antiemetika
- Gastrointestinální látky
- Antipsychotické látky
- Uklidňující prostředky
- Psychotropní drogy
- Inhibitory vychytávání serotoninu
- Inhibitory vychytávání neurotransmiterů
- Membránové transportní modulátory
- Serotoninové látky
- Olanzapin
Další identifikační čísla studie
- 12117
- F1D-MC-HGMX (Jiný identifikátor: Eli Lilly and Company)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .