Overview

This trial is active, not recruiting.

Condition schizophrenia
Treatment paliperidone er
Phase phase 3
Sponsor Janssen-Cilag International NV
Start date April 2007
End date January 2009
Trial size 1812 participants
Trial identifier NCT00460512, 2006-004265-34, CR012949, R076477SCH3017

Summary

The purpose of this study is to explore tolerability, safety and effectiveness 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 an oral antipsychotic medication.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
paliperidone er
Paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons.

Primary Outcomes

Measure
Percentage of Participants With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score in Those Participants who Transitioned due to Lack of Efficacy
time frame: Endpoint (up to Week 26)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint (up to Week 26)
time frame: Baseline and endpoint (up to Week 26)

Secondary Outcomes

Measure
Percentage of Participants With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score
time frame: Endpoint (up to Week 26)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Endpoint (up to Week 26)
time frame: Baseline and endpoint (up to Week 26)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Endpoint (up to Week 26)
time frame: Baseline and endpoint (up to Week 26)
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint (up to Week 26)
time frame: Baseline and endpoint (up to Week 26)
Change From Baseline in Total Personal and Social Performance (PSP) Score at Endpoint (up to Week 26)
time frame: Baseline and endpoint (up to Week 26)
Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Endpoint (up to Week 26)
time frame: Baseline and endpoint (up to Week 26)
Number of Participants With Satisfaction With the Study Treatment
time frame: Endpoint (up to Week 26)
Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Endpoint (up to Week 26)
time frame: Baseline and endpoint (up to Week 26)
Change From Baseline in Extrapyramidal Symptoms Rating Scale (ESRS) Total Score at Endpoint (up to Week 26)
time frame: Baseline and endpoint (up to Week 26)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Participant meets the Diagnostic and Statistical Manual of Mental Disorders (Edition 4) criteria for schizophrenia - Participant is previously non-acute (on the same antipsychotic medication used for the treatment of schizophrenia and Clinical Global Impression-Severity [CGI-S] change less than or equal to 1 in the past 4 weeks before enrollment) and has been given an adequate dose of an appropriate oral 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 effectiveness, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication - Participant is healthy on the basis of a physical examination and vital signs at screening - 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 - Participants must be willing and able to fill out self-administered questionnaires Exclusion Criteria: - Participants on clozapine, any conventional depot neuroleptic or risperidone long-acting injection 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) and 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 judged to be at high risk for adverse events, violence or self-harm - Participants with a current use or known history (over the past 6 months) of substance dependence according to Diagnostic and Statistical Manual of Mental Disorders (Edition 4) Criteria

Additional Information

Official title An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
Description This is a 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) 6-month study. Participants can be transitioned to an effective dose of paliperidone ER from any oral antipsychotic medication 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 6 months. Adjustment of the dosage will be done at Investigator's discretion, based on the individual participant's clinical response and tolerability of the study drug dosages. Participants who complete this 6-month study and would like to continue will be eligible to be enrolled in an extension phase until paliperidone ER is available. The starting dose of the extension phase will be the same as at the end of the 6-month study and may be changed throughout the extension period. The extension phase will consist of a main extension phase (ending with an End of Main Extension Phase Visit) and a modified extension phase (ending with an End of Study Visit). Efficacy will primarily be evaluated by positive and negative syndrome scale (PANSS). Safety will primarily be evaluated by Extrapyramidal Symptom Rating Scale (ESRS).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Janssen-Cilag International NV.