- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00757705
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia
5. února 2014 aktualizováno: Johnson & Johnson Taiwan Ltd
An Open-label Prospective Trial to Evaluate the Tolerability, Safety and Maintained Efficacy of a Transition to Paliperidone ER in Subjects With Schizophrenia Previously Unsuccessfully Treated With Other Oral Antipsychotics
The purpose of the study is to explore the maintained efficacy, tolerability, and safety of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with other oral atypical antipsychotic medication.
Přehled studie
Detailní popis
This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance), single arm, multicenter (when more than one hospital or medical school team work on a medical research study), 24-week study.
Participants can be transitioned to an effective dose of paliperidone ER from any oral antipsychotic medication without the need for titration due to lack of efficacy, lack of tolerability or safety, lack of compliance or other reason.
A transition period of maximum 4 weeks will be allowed.
Throughout the study, participants will receive flexible dose of 3 to 12 milligram (mg) of paliperidone once daily orally for 24 weeks.
Dose adjustment will be done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug.
Assessments of efficacy will be performed at screening and after 2, 4, 12 and 24 weeks.
Efficacy will primarily be evaluated by means of Positive and Negative Syndrome Scale (PANSS).
Participants' safety will also be monitored throughout the study.
Typ studie
Intervenční
Zápis (Aktuální)
299
Fáze
- Fáze 4
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
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
- Participant has been given an adequate dose of an appropriate oral atypical antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
- Participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must also have a negative urine pregnancy test at screening
- Male or female, aged greater than or equal to 18 years
Exclusion Criteria:
- Participants on clozapine, any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months
- Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
- Participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
- Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
- Participants with a current use or known history (over the past 6 months) of substance dependence except for nicotine, caffeine, and betal nut according to DSM-IV Criteria
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: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Paliperidone Extended-Release (ER)
|
Participants will receive paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day orally once daily for 24 weeks as per Investigator's discretion based on the individual participant's clinical response to and tolerability of the study drug.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24
Časové okno: Baseline, Week 24
|
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme).
The total score ranges from 30 to 210 and higher score indicates greater severity.
|
Baseline, Week 24
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24
Časové okno: Baseline, Week 24
|
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia.
The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology).
Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28.
Higher score indicates greater severity.
|
Baseline, Week 24
|
Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score
Časové okno: Up to Week 24
|
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme).
The total score ranges from 30 to 210 and higher score indicates greater severity.
|
Up to Week 24
|
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
Časové okno: Baseline, Week 24
|
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function.
Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
|
Baseline, Week 24
|
Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24
Časové okno: Baseline, Week 24
|
The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults.
The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms.
The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.
|
Baseline, Week 24
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24
Časové okno: Baseline, Week 24
|
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.
A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants".
|
Baseline, Week 24
|
Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24
Časové okno: Baseline, Week 24
|
The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS).
Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively.
All items are scored so that a high score defines a more favorable health state.
|
Baseline, Week 24
|
Number of Participants With Satisfaction With the Study Treatment
Časové okno: Week 24
|
Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor).
|
Week 24
|
Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24
Časové okno: Baseline, Week 24
|
The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness.
Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time).
|
Baseline, Week 24
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
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. března 2008
Primární dokončení (Aktuální)
1. května 2009
Dokončení studie (Aktuální)
1. května 2009
Termíny zápisu do studia
První předloženo
19. září 2008
První předloženo, které splnilo kritéria kontroly kvality
19. září 2008
První zveřejněno (Odhad)
23. září 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
6. února 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
5. února 2014
Naposledy ověřeno
1. února 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
- Antipsychotické látky
- Uklidňující prostředky
- Psychotropní drogy
- Serotoninové látky
- Dopaminové látky
- Antagonisté serotoninového 5-HT2 receptoru
- Antagonisté serotoninu
- Antagonisté dopaminového D2 receptoru
- Antagonisté dopaminu
- Paliperidon palmitát
Další identifikační čísla studie
- CR014308
- R076477SCH4033
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 .
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