- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00757705
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia
5 februari 2014 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
299
Fas
- Fas 4
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2008
Primärt slutförande (Faktisk)
1 maj 2009
Avslutad studie (Faktisk)
1 maj 2009
Studieregistreringsdatum
Först inskickad
19 september 2008
Först inskickad som uppfyllde QC-kriterierna
19 september 2008
Första postat (Uppskatta)
23 september 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
6 februari 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 februari 2014
Senast verifierad
1 februari 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Schizofrenispektrum och andra psykotiska störningar
- Schizofreni
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Antipsykotiska medel
- Lugnande medel
- Psykotropa droger
- Serotoninmedel
- Dopaminmedel
- Serotonin 5-HT2-receptorantagonister
- Serotoninantagonister
- Dopamin D2-receptorantagonister
- Dopaminantagonister
- Paliperidonpalmitat
Andra studie-ID-nummer
- CR014308
- R076477SCH4033
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Paliperidone ER
-
Janssen-Cilag International NVAvslutad
-
Janssen Research & Development, LLCAvslutad
-
Watson PharmaceuticalsAvslutadAnemi, järnbrist | Hemodialys | Njursvikt, kroniskFörenta staterna
-
Sage TherapeuticsAvslutadEssentiell tremorFörenta staterna
-
Johnson & Johnson Pharmaceutical Research & Development...AvslutadSchizofreni | Schizoaffektiv sjukdom | Schizofreniforma sjukdomar
-
Johnson & Johnson Pharmaceutical Research & Development...Avslutad
-
Johnson & Johnson Taiwan LtdAvslutad
-
Xiaoxiang ChenRekryteringÄggstockscancer | PARP-hämmare | Klinisk markörKina
-
Wei HaoAvslutadMetamfetaminberoendeKina
-
Wei HaoAvslutad