Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years

NCT01362439 | Completed Phase 4 Results

• 3 other identifiers: CR017578R076477SCH30372008-002384-13
• Study Type: interventional
• Target: 133
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were receiving treatment with any oral (having to do with the mouth) antipsychotic medication and who needed to be switched to paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or due to side effects.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13

  The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and 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 the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.

  Baseline and Week 13

Secondary Outcomes (11)

• Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13

  Baseline and Week 13

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13

  Baseline and Week 13

• Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13

  Baseline and Week 13

• Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score

  Baseline and Week 13

• Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13

  Baseline and Week 13

Study Arms (1)

Paliperidone ER

EXPERIMENTAL

Drug: Paliperidone ER

Interventions

Paliperidone ER DRUG

Participants will be administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose will be increased or decreased as per Investigator's discretion.

Paliperidone ER

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
• Positive and Negative Syndrome Scale (PANSS) total score at Baseline of greater than equal to 70 and less than equal to 100
• Participants who need to be switched from the current oral antipsychotic therapy because of lack of efficacy or side effects
• Participants followed as outpatients
• Female participants must be postmenopausal for at least 1 year, surgically sterile or, if sexually active, be practicing an effective method of birth control and female participants of childbearing potential must also have a negative urine pregnancy test at Baseline

You may not qualify if:

• Acute psychotic relapse that requires hospitalization and first antipsychotic treatment ever
• Participants who had received clozapine during the previous 3 months
• 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)
• Pregnant or breast-feeding female
• Participated in an investigational drug trial in the previous 30 days

Sponsors & Collaborators

• Janssen-Cilag S.p.A.: 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

Results Point of Contact

• Title: Therapeutic Area Medical Manager
• Organization: Janssen-Cilag SpA, Cologno Monzese, Milan - Italy

+39 0225101

Study Officials

• Janssen-Cilag S.p.A. Italy Clinical Trial

  Janssen-Cilag S.p.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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: May 26, 2011
• First Posted: May 30, 2011
• Study Start: January 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 5, 2013
• Results First Posted: June 5, 2013

Record last verified: 2013-04