An Efficacy and Safety Study of Paliperidone Extended-Release (ER) Tablets in Participants With Schizophrenia

NCT00566631 | Completed Phase 3 Results

• 2 other identifiers: CR013162R076477SCH3018
• Study Type: interventional
• Target: 294
• Locations: 7 countries
• Sites: 30

Brief Summary

The purpose of this study is to evaluate the tolerability, safety and treatment response of flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with acute schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone Extended Release (ER); Invega

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Response Based on Total PANSS Scale Score

  Response was defined as decrease of at least 30 percent in total Positive and Negative Syndrome Scale (PANSS) score from Baseline to endpoint of core phase (which is, Day 42 or early discontinuation). The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, \& poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of sum of all 30 PANSS items \& ranges from 30 to 210. Higher scores indicate worsening.

  Day 42 or early discontinuation

Secondary Outcomes (8)

• Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)

  Baseline, Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)

  Baseline, Day 42 and Final Evaluation (Day 42 or early discontinuation)

• Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score

  Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)

• Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)

  Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)

• Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)

  Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)

Other Outcomes (3)

• Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)

  Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)

• Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)

  Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)

• Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)

  Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)

Study Arms (1)

Paliperidone Extended Release (ER)

EXPERIMENTAL

Drug: Paliperidone

Interventions

Paliperidone DRUG

Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion will be given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.

Also known as: 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:

• Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia
• Must be experiencing an acute schizophrenic episode with a Positive and Negative Syndrome Scale (PANSS) total score of greater than or equal to 70 at Baseline
• Must be admitted to hospital for treatment of the acute schizophrenic episode and must agree for voluntary hospitalization for at least the first 7 days of the study
• Female participants must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study and female participants of child-bearing potential must have a negative urine pregnancy test at Screening
• Participants 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

You may not qualify if:

• Pregnant or breast-feeding female participants
• First antipsychotic treatment ever
• Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment and on clozapine or a long-acting injectable antipsychotic during the last 3 months
• Known hypersensitivity to paliperidone extended-release (ER) or risperidone
• Relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome including recent or present clinically relevant laboratory abnormalities (as deemed by the Investigator) and participants with current or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (30)

Unknown Facility

Zagreb, Croatia

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Dieppe, France

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La Charité-sur-Loire, France

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Metz, France

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Augsburg, Germany

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Bonn, Germany

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Mainz, Germany

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Mannheim, Germany

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München, Germany

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Rostock, Germany

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Wasserburg, Germany

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Be-Er Ya-Acov, Israel

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Beersheba, Israel

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Hod HaSharon, Israel

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Pardesiyya, Israel

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Ramat Gan, Israel

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Klaipėda, Lithuania

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Šiauliai, Lithuania

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Vilnius, Lithuania

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Gda Sk Poland, Poland

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Gmina Świecie, Poland

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Lodz, Poland

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Lublin, Poland

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Lubliniec, Poland

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Skąpe, Poland

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Torun, Poland

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Ząbki, Poland

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Bucharest, Romania

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Cluj-Napoca, Romania

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Craiova, Romania

Location

Related Links

• Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia

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

Results Point of Contact

• Title: EMEA Therapeutic Area Leader CNS
• Organization: Janssen-Cilag Germany

+492137955153

Study Officials

• Janssen-Cilag International NV, Belgium Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: December 3, 2007
• Study Start: July 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2009
• Last Updated: August 2, 2013
• Results First Posted: August 2, 2013

Record last verified: 2013-06

Locations

CR (1); IL (5); RO (3); DE (7); FR (3); LI (3); PL (8)