An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia

NCT00757705 | Completed Phase 4 Results

• 2 other identifiers: CR014308R076477SCH4033
• Study Type: interventional
• Target: 299
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone Extended-Release

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 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

Secondary Outcomes (8)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24

  Baseline, Week 24

• Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score

  Up to Week 24

• Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24

  Baseline, Week 24

• Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24

  Baseline, Week 24

• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24

  Baseline, Week 24

Study Arms (1)

Paliperidone Extended-Release (ER)

EXPERIMENTAL

Drug: Paliperidone ER

Interventions

Paliperidone ER DRUG

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.

Also known as: R076477, Invega

Paliperidone Extended-Release (ER)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Taiwan Ltd: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.

Results Point of Contact

• Title: Medical Director
• Organization: Janssen Research & Development

886 2 23762155

Study Officials

• Johnson & Johnson Taiwan, Ltd. Clinical Trial

  Johnson & Johnson Taiwan Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 23, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: February 6, 2014
• Results First Posted: February 6, 2014

Record last verified: 2014-02