Symptomatic Remission and Social Function in Participants Treated With Paliperidone Extended Release (ER)

NCT01577186 | Completed Phase 4 Results

• 3 other identifiers: CR015667R076477SCH4035PAL-TWN-MA3
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to explore the relationship between achieving symptomatic remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and personal and social functioning by means of the Personal and Social Performance (PSP) scale in participants treated with flexibly dosed paliperidone ER.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone Extended Release

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)

  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), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.

  End of study (Up to Week 12)

• Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale

  The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.

  End of study (Up to Week 12)

Secondary Outcomes (1)

• Social Functioning Scale (SFS) Score

  End of study (Up to Week 12)

Other Outcomes (2)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12

  Baseline, Week 12

• Change From Baseline in Total Personal and Social Performance (PSP) 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 tablet in flexible dose range of 3 to 12 milligram per day (mg/day) orally once daily up to Week 12 as per Investigator's discretion.

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:

• Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th 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)
• Participant is drug naive or participant's 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
• Participants or their legally acceptable representatives had signed an informed consent document indicating that they understand the purpose of and procedures required for the study and were willing to participate in the study
• Women 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 have a negative urine pregnancy test at screening

You may not qualify if:

• Participants with use of clozapine, paliperidone extended release (ER), 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 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 known hypersensitivity to paliperidone ER or risperidone
• Participants with inability to swallow the whole study medication tablet with aid of water

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: July 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 17, 2014
• Results First Posted: January 17, 2014

Record last verified: 2013-12