NCT01150448

Brief Summary

The purpose of this study is to evaluate the long term safety of flexible doses (50 to 150 mg equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to document the pharmacokinetics of paliperidone following fixed multiple intramuscular injections of paliperidone palmitate 150 mg eq.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started Sep 2007

Typical duration for phase_1 schizophrenia

Geographic Reach
10 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 17, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

1.8 years

First QC Date

June 17, 2010

Last Update Submit

May 26, 2014

Conditions

Schizophrenia

Keywords

Paliperidone palmitatepaliperidone ER (INVEGA)R092670PSY1008RisperidoneRisperdal (RISPERDAL CONSTA)Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • The number of patients experiencing treatment emergent adverse events

    Screening (Day -21 to -1) to Day 372 (or at the time of early termination from the study)

  • Concentration of paliperidone in plasma from blood samples obtained from patients

    Day 1 to Day 372

Secondary Outcomes (4)

  • Changes in Sleep Visual Analog Scale (Sleep VAS) scores as an indicator of quality of sleep and daytime drowsiness

    Day 1 to Day 372.

  • Changes in Positive and Negative Syndrome Scale (PANSS) scores

    Day 1 to Day 372.

  • Change in Clinical Global Impression Severity of Illness (CGI-S) Scores as an indicator of overall clinical condition

    Day 1 to Day 372.

  • Changes in Personal and Social Performance Scale (PSP) Scores (measures personal and social performance in patients with acute symptoms of schizophrenia. Higher PSP scores indicate better personal and social functioning)

    Day 1 to Day 372.

Study Arms (2)

001

EXPERIMENTAL

Paliperidone palmitate Treatment A All patients will receive a single IM injection of 150mg eq of study drug on Day 1. Patients who tolerate 150mg eq will receive a 2nd IM injection of 150mg eq on Day 8 followed by 12 IM injections (1 every 4 weeks) of 150mg eq. All other patients will be assigned to Treatment B.

Drug: Paliperidone palmitate Treatment A

002

EXPERIMENTAL

Paliperidone palmitate Treatment B Patients not tolerating Treatment A will receive a single IM injection of study drug 100mg eq at their next scheduled visit followed by injections (1 every 4 weeks) ranging from 50 to 150mg eq patients who do not wish to have multiple blood samples collected will also be assigned to Treatment B

Drug: Paliperidone palmitate Treatment B

Interventions

Paliperidone palmitate Treatment ADRUG

All patients will receive a single IM injection of 150mg eq of study drug on Day 1. Patients who tolerate 150mg eq will receive a 2nd IM injection of 150mg eq on Day 8 followed by 12 IM injections (1 every 4 weeks) of 150mg eq. All other patients will be assigned to Treatment B.

001
Paliperidone palmitate Treatment BDRUG

Patients not tolerating Treatment A will receive a single IM injection of study drug 100mg eq at their next scheduled visit followed by injections (1 every 4 weeks) ranging from 50 to 150mg eq

002

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for at least 1 year before screening
  • Have a body mass index (BMI) of \>=17.0 kg/m2 at screening
  • Have a Positive and Negative Syndrome Scale (PANSS) total score of \<=70

You may not qualify if:

  • Have a primary active DSM-IV Axis I diagnosis other than schizophrenia
  • Have a PANSS total score of \>70 at screening
  • Have a PANSS score of \>16 points on the sum of the following 4 items at screening and baseline: conceptual disorganization, suspiciousness/persecution, hallucinatory behavior, and unusual thought content
  • Have scores greater than 5 on any of the individual items of the PANSS at screening or baseline
  • Have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior as clinically assessed by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Unknown Facility

Cerritos, California, United States

Location

Unknown Facility

National City, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Zagreb, Croatia

Location

Unknown Facility

Kuala Lumpur, Malaysia

Location

Unknown Facility

Leszno, Poland

Location

Unknown Facility

Lubliniec, Poland

Location

Unknown Facility

Poznan, Poland

Location

Unknown Facility

Torun, Poland

Location

Unknown Facility

Bratislava, Slovakia

Location

Unknown Facility

Michalovce, Slovakia

Location

Unknown Facility

Rimavská Sobota, Slovakia

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Badalona, Spain

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Hualien City, Taiwan

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Taoyuan District, Taiwan

Location

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Chiang Mai, Thailand

Location

Related Publications (1)

  • Coppola D, Liu Y, Gopal S, Remmerie B, Samtani MN, Hough DW, Nuamah I, Sulaiman A, Pandina G. A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia. BMC Psychiatry. 2012 Mar 28;12:26. doi: 10.1186/1471-244X-12-26.

    PMID: 22455454DERIVED

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 25, 2010

Study Start

September 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

TH(2)SL(3)US(5)BE(1)ES(3)KR(3)MY(1)PL(4)CR(1)TW(5)