A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone

NCT01010776 | Completed Phase 4 Results

• 2 other identifiers: CR013744R076477SCH4011
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to evaluate effectiveness, tolerability (how well a participant can stand a particular medicine or treatment), and safety of flexible-dose of 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 taking risperidone (an antipsychotic), but who are not satisfied with their treatment.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase

  The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia 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 26

• Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase

  The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia 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 52

Secondary Outcomes (14)

• Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase

  Week 26

• Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase

  Week 52

• Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase

  Baseline, Week 4, 8, 13 and 26

• Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase

  Baseline, Week 4, 8, 13, 26, 39 and 52

• Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase

  Baseline, Week 4, 8, 13 and 26

Other Outcomes (2)

• Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase

  Baseline, Week 4, 8, 13 and 26

• Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase

  Baseline, Week 4, 8, 13, 26, 39 and 52

Study Arms (1)

Paliperidone Extended Release (ER)

EXPERIMENTAL

Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.

Drug: Paliperidone Extended Release (ER)

Interventions

Paliperidone Extended Release (ER) DRUG

Paliperidone ER tablets in the flexible dose ranging from 3 to 12 mg will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.

Paliperidone Extended Release (ER)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants must be postmenopausal (after the time in life when a woman stops having a menstrual period) or surgically sterile or if sexually active, practicing an effective method of birth control (e.g., oral contraceptive, intrauterine device \[IUD - an intrauterine device made of plastic and/or copper that is inserted into the womb \[uterus\] by way of the vaginal canal to used to prevent pregnancy\], diaphragm with spermicide \[agent that kills spermatozoa\] or condom \[cover worn over the penis during sexual intercourse to prevent infection or pregnancy\] with spermicide) throughout the study and have a negative serum beta - Human Chorionic Gonadotropin (HCG) pregnancy test at screening
• Participants on oral monotherapy (treatment with a single drug) with risperidone in a regimen within the daily dosage recommended by the package insert and adhering to the prescribed risperidone regimen for at least 30 days before entering the study
• Participants with partial response to the current risperidone regimen (persistent symptoms or unstable clinical condition) or presence of unbearable side effects
• Potential Participants switching to another atypical antipsychotic due to their clinical response and/or side effects profile.

You may not qualify if:

• Participants with past or current history of psychiatric disease other than schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV
• Participants with concomitant (given at the same time) severe (very serious, life threatening) medical or neurological disorder or risk of suicide
• Participants previously using clozapine
• Participants with a history of previous non-responsiveness to oral antipsychotic treatment
• Pregnant or breast-feeding female participants

Sponsors & Collaborators

• Janssen-Cilag Farmaceutica Ltda.: lead

Study Sites (10)

Unknown Facility

Belo Horizonte, Brazil

Location

Unknown Facility

Criciúma, Brazil

Location

Unknown Facility

Curitiba, Brazil

Location

Unknown Facility

Goiânia, Brazil

Location

Unknown Facility

Itapira, Brazil

Location

Unknown Facility

Marília, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

Salvador, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Sorocaba, Brazil

Location

Related Publications (1)

• Gattaz WF, Campos JA, Lacerda AL, Henna E, Ruschel SI, Bressan RA, de Oliveira IR, Rocha FL, Grabowski HM, Sacomani E Jr, Louza MR, Quevedo J, Elkis H, Zorzetto Filho D, Perico Cde A, Lawson FL, Appolinario JC. Switching from oral risperidone to flexibly dosed oral paliperidone extended-release: core symptoms, satisfaction, and quality of life in patients with stable but symptomatic schizophrenia: the RISPALI study. Curr Med Res Opin. 2014 Apr;30(4):695-709. doi: 10.1185/03007995.2013.869201. Epub 2013 Dec 16.

  PMID: 24289141 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Group Manager
• Organization: Jan-Cil Brazil

55 11 3030-2770

Study Officials

• Janssen-Cilag Farmaceutica Ltda. Clinical Trial

  Janssen-Cilag Farmaceutica Ltda.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: November 5, 2009
• First Posted: November 10, 2009
• Study Start: February 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 20, 2013
• Results First Posted: November 20, 2013

Record last verified: 2013-09

Locations

BR (10)