- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01541371
A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia
July 3, 2013 updated by: Xian-Janssen Pharmaceutical Ltd.
An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Non Acute Episode Subjects With Schizophrenia
The purpose of this study is to evaluate the effectiveness of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self) who were not satisfied with other prior antipsychotics (agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect; olanzapine, quetiapine and risperidone) they had been taking.
The safety and tolerability of paliperidone ER tablets will also be assessed.
Study Overview
Detailed Description
This is an open label (all people know the identity of the intervention), prospective (study following participants forward in time), non-randomized (the study drug is not assigned by chance, participants may choose which group they want to be in, or they may be assigned to the groups by the researchers), single-arm (getting one dose of medicine) and multi-center (when more than one hospital or medical school team work on a medical research study) study designed to determine the efficacy, tolerability and safety of flexible dosage of paliperidone ER tablets in treatment of participants with schizophrenia not satisfied with other prior antipsychotics.
The duration of the study will be 12 weeks.
All participants will be given paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks; initial dose for paliperidone ER will be 6 mg/day.
The primary objective will be to evaluate the efficacy of treatment with paliperidone ER using Positive and Negative Symptom Scale (PANSS) total scores.
Participants safety and tolerability will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
405
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis criteria of schizophrenia
- Participant 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
- Participant 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
- 7. 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. Effective methods of birth control include prescription hormonal contraceptives, contraceptive injections, intrauterine devices, double barrier method, contraceptive patch and male partner sterilization. Female participants must also have a negative urine pregnancy test at screening
- Participant willing to and who could complete questionnaire by himself
Exclusion Criteria:
- Participant receiving treatment with clozapine or risperidone microspheres for injection (Hengde) within 3 months before screening
- Participant having history of seizure except febrile convulsion (seizures that occur during a febrile episode [fever])
- Participant having refractory schizophrenia (previous treatment with unsatisfied efficacy of 2 or more than 2 kinds of antipsychotics with different chemical structure after adequate dose and duration)
- Participant receiving electric shock treatment within 1 month before screening
- Participant having serious, unstable physical diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paliperidone ER
|
Paliperidone Extended Release (ER) 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
Time Frame: Baseline and Week 12
|
PANSS is a medical scale that assesses various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self).
The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology).
The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
|
Baseline and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12
Time Frame: Baseline and Week 12
|
PANSS is a medical scale that assesses various symptoms of schizophrenia.
The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology).
The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
Positive syndrome subscale ranges from 7 to 49, higher change scores indicate worsening.
Negative syndrome subscale ranges from 7 to 49, higher change scores indicate worsening.
General Psychopathology subscale ranges from 16 to112, higher change scores indicate worsening.
|
Baseline and Week 12
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12
Time Frame: Baseline and Week 12
|
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).
Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28.
Higher change score indicates greater severity.
|
Baseline and Week 12
|
Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Week 12
|
PANSS is a medical scale that assesses various symptoms of schizophrenia.
The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology).
The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
Percentage of participants with at least 20 percent improvement of PANSS total score was measured.
|
Week 12
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12
Time Frame: Baseline and Week 12
|
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".
Higher change scores indicate worsening.
|
Baseline and Week 12
|
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12
Time Frame: Baseline and Week 12
|
PSP assesses the degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior.
The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains.
Based on the four domains there will be one total score.
Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =<30, functioning so poorly as to require intensive supervision.
|
Baseline and Week 12
|
Number of Participants With Satisfaction With the Study Treatment
Time Frame: Baseline and Week 12
|
Participants assessed their satisfaction with paliperidone ER on a 5-point scale: 1 (very good), 2 (good), 3 (moderate), 4 (poor) and 5 (very poor).
|
Baseline and Week 12
|
Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12
Time Frame: Baseline and Week 12
|
The self-administered sleep VAS scale (0-100 milimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD).
Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).
|
Baseline and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
February 23, 2012
First Submitted That Met QC Criteria
February 23, 2012
First Posted (Estimate)
February 29, 2012
Study Record Updates
Last Update Posted (Estimate)
August 7, 2013
Last Update Submitted That Met QC Criteria
July 3, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Paliperidone Palmitate
Other Study ID Numbers
- CR016165
- R076477-SCH-3035
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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