Clinical trial NCT00757705: An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone Extended-Release
Lead sponsor: Johnson & Johnson Taiwan Ltd
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Up to Week 24
measure: Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24
timeFrame: Baseline, Week 24
measure: Number of Participants With Satisfaction With the Study Treatment
timeFrame: Week 24
measure: Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Taiwan Ltd
name: Johnson & Johnson Taiwan, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: