A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia

NCT01577160 | Completed Phase 4 Results

• 3 other identifiers: CR015664R076477SCH4034PAL-TWN-MA2
• Study Type: interventional
• Target: 353
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone Extended Release (ER)

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale

  The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as "1: very much improved" or "2: much improved" on the CGI-I scale at Week 12.

  Week 12

Secondary Outcomes (4)

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12

  Baseline, Week 12

• Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score

  Week 12

• Change From Baseline in Personal and Social Performance (PSP) Score at Week 12

  Baseline, Week 12

• Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12

  Baseline, Week 12

Study Arms (1)

Paliperidone Extended Release (ER)

EXPERIMENTAL

Drug: Paliperidone ER

Interventions

Paliperidone ER DRUG

Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.

Paliperidone Extended Release (ER)

Eligibility Criteria

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

You may qualify if:

• Participants who are diagnosed with schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders \[Edition 4\] criteria)
• Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
• Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
• Participants who are capable of and willing to fill out the questionnaire for themselves
• Participants who are compliant with self-medication or can receive consistent help or support

You may not qualify if:

• Participants with the past 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 allergy or hypersensitivity to risperidone or paliperidone
• Participants who have taken clozapine, or have been exposed to the study drug within one month before screening
• Participants who have been treated with the long acting antipsychotic injection within 28 days
• Participants with significant risk including suicide or aggressive behavior

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: April 12, 2012
• First Posted: April 13, 2012
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 14, 2014
• Results First Posted: January 14, 2014

Record last verified: 2013-11