A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Patients With Schizophrenia
This study has been completed.
Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Information provided by:
Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier:
NCT01541371
First received: February 23, 2012
Last updated: March 6, 2012
Last verified: March 2012
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Purpose
The purpose of this study is to evaluate efficacy of treatment with paliperidone extended-release (ER) tablets in patients with schizophrenia who were not satisfied with other antipsychotics (Olanzapine, Quetiapine and Risperidone) they had been taking. The safety and tolerability of paliperidone ER tablets will also be assessed.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Paliperidone ER |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Efficacy, Safety and Tolerability After Switching to Flexible Dosage of Paliperidone Extended Release Tablets in Treatment of Patients With Non-acute Phase of Schizophrenia in an Open-Label, Prospective Study |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Paliperidone
U.S. FDA Resources
Further study details as provided by Xian-Janssen Pharmaceutical Ltd.:
Primary Outcome Measures:
- Changes in Positive and Negative Symptom Scale (PANSS) total scores [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]The PANSS consistes of a total scores (all 30 items) and scores in 3 subscales, positive subscale (7 items), negative subscale (7 items), general psychopathology subscale (16 items). Patients were to be rated in every scale rate from 1(absent) to 7 (extremely serious).
Secondary Outcome Measures:
- Change in PANSS subscale scores [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]The PANSS consistes of a total scores (all 30 items) and scores in 3 subscales, positive subscale (7 items), negative subscale (7 items), general psychopathology subscale (16 items). Patients were to be rated in every scale rate from 1(absent) to 7 (extremely serious).
- Change in the Clinical Global Impressions (CGI) scale [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]The CGI scale is a 7-point scale rating from 1(normal, not at all illness) to 7 (extremely ill). The CGI scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments of patients.
- Change in personal and social function by Personal and Social Performance (PSP) scale [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]The PSP scale with its four sub dimensions was used to evaluate the severity of psychosocial functioning in patient within 1month, consisting of a) Socially useful activities; b) personal and social relationships; c) self-care; d) disturbing and aggressive behavior. The scores ranged from 1 to 100, the severity in every sub dimension was divided into 10 equivalent scores range (i, absent-vi, extremely). Score 71-100 indicated mild difficult; score 31-70 various degree of disability; Score≤30 extremely illness, so that intense care was needed.
- Change in patient satisfaction with treatment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]The degrees of satisfaction with present treatment were assessed by a 5-point scale (very satisfied, satisfied, in general, dissatisfied, very dissatisfied).
- Change in sleep quality and level of daytime sleepiness [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]The quality of sleep and level of daytime sleepiness in patients were to be assessed, as determined by Visual Analogue scale.
- Percentage of patients with a ≥20% reduction of PANSS total scores at endpoint from baseline [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]The PANSS consistes of a total scores (all 30 items) and scores in 3 subscales, positive subscale (7 items), negative subscale (7 items), general psychopathology subscale (16 items). Patients were to be rated in every scale rate from 1(absent) to 7 (extremely serious).
| Enrollment: | 408 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Paliperidone ER |
Drug: Paliperidone ER
Type= exact number, unit= mg, number= 3, 6 or 9, form= tablet, route= oral use. Paliperidone ER tablet(s), with dose ranged from 3 mg to 12 mg once daily, for 12 weeks.
|
Detailed Description:
This was a 12-week study designed to determine the efficacy, tolerability and safety of flexible dosage of paliperidone extended-release (ER) tablets in treatment of patients with schizophrenia not satisfied with other prior antipsychotics. During the period of study, the dose of paliperidone ER tablets was adjusted in the range of 3mg-12mg/day, and investigator could select dose for patients by individual dose adjustment. Initial dose for paliperidone extended-release was 6mg/day.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Meet Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis criteria of schizophrenia
- Patient receiving full course of treatment (6-8 weeks) at correct dose (dose range recommended by the instruction) of Risperdal, Zyprexa or Seroquel before enrollment, was poorly controlled and had to change medication because of unsatisfying efficacy, tolerability or safety issues, or other reason
- Patient in the non-acute phase during screening received treatment with any of above three antipsychotics within 4 weeks before enrollment and state of illness was relatively stable
- Patient and his/her legal guardian could read, understand and sign informed consent (signed by both)
Exclusion Criteria:
- Patient received treatment with Clozapine or Risperidone microspheres for injection (Hengde) within 3 months before screening
- Patient received any typical long-acting antipsychotics within 1 month before screening
- Patient had refractory schizophrenia (previous treatment with unsatisfied efficacy of two or more than two kinds of antipsychotics with different chemical structure after adequate dose and duration)
- Patient had history of seizure except febrile convulsion
- Patient received electric shock treatment within 1 month before screening
- Patient meeting any additional exclusion criteria as specified in the study protocol
Contacts and Locations More Information
No publications provided
| Responsible Party: | VP CHINA R D AND SCIENTIFIC AFFAIRS, Xian-Janssen Pharmaceutical Ltd., China |
| ClinicalTrials.gov Identifier: | NCT01541371 History of Changes |
| Other Study ID Numbers: | CR016165, R076477-SCH-3035 |
| Study First Received: | February 23, 2012 |
| Last Updated: | March 6, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
|
Schizophrenia Paliperidone extended-release tablets |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders 9-hydroxy-risperidone Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013