Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants

NCT01387542 | Completed Phase 4 Results

• 2 other identifiers: CR015976R076477SCH4037
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) treatment in Thai 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); INVEGA

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10

  The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening .

  Baseline, Week 10

• Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2

  The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.

  Baseline, Week 2

• Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6

  The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.

  Baseline, Week 6

• Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10

  The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.

  Baseline, Week 10

Study Arms (1)

Paliperidone Extended Release (ER)

EXPERIMENTAL

Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks

Drug: Paliperidone extended release (ER)

Interventions

Paliperidone extended release (ER) DRUG

Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks

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:

• Meet the Diagnostic and Statistical Manual of Mental Disorders (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)
• Participants unsatisfied with their previous treatment
• Previously or currently on oral atypical antipsychotics

You may not qualify if:

• Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
• 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)
• 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)
• Pregnant or breast-feeding female
• Participation in an investigational drug trial within 30 days prior to selection

Sponsors & Collaborators

• Janssen-Cilag Ltd.,Thailand: lead

Study Sites (2)

Unknown Facility

Chiang Mai, Thailand

Location

Unknown Facility

Songkhla, Thailand

Location

Related Links

• An Open-label, PRospective Study to Evaluate Social Function and Overall Improvement of Paliperidone ER Treatment in Thai Schizophrenia PatieNT (PRESENT)

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

Study had an open-label trial design with lack of a comparator arm; therefore it was difficult to conclude the efficacy and safety results.

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Janssen-Cilag Ltd.: 106 Moo 4 Lad Krabang Industrial Estate, Chalongkrung Rd., Lamplatew, Lad Krabang, Bangkok 10520

+66 2 7397200

Study Officials

• Janssen-Cilag Ltd.,Thailand Clinical Trial

  Janssen-Cilag Ltd.,Thailand

  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: June 30, 2011
• First Posted: July 4, 2011
• Study Start: August 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 5, 2013
• Results First Posted: March 5, 2013

Record last verified: 2013-01

Locations

TH (2)