A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia

NCT01606228 | Completed Phase 3 Results

• 3 other identifiers: CR014452R076477SCH3033PAL-PHL-MA3
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone ER; Treatment naive patients; Newly diagnosed patients

Outcome Measures

Primary Outcomes (1)

• The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)

  The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening.

  Baseline, Day 90

Secondary Outcomes (11)

• Positive and Negative Syndrome Scale (PANSS) Scores at Baseline

  Baseline

• Positive and Negative Syndrome Scale (PANSS) Scores at Day 90

  Day 90

• Clinical Global Impression-Severity (CGIS) Scores at Baseline

  Baseline

• Clinical Global Impression-Severity (CGIS) Scores at Day 90

  Day 90

• Personal and Social Performance (PSP) Scores at Baseline

  Baseline

Study Arms (1)

Paliperidone ER

EXPERIMENTAL

Drug: Paliperidone ER

Interventions

Paliperidone ER DRUG

Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.

Paliperidone 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:

• Patients diagnosed with schizophrenia
• Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening
• Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
• Patient healthy on the basis of a physical examination, laboratory examination, and vital signs
• Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study

You may not qualify if:

• Serious unstable medical condition, including known clinically relevant laboratory abnormalities
• Judged to be at high risk for adverse events, violence or self-harm
• Inability to swallow the study medication whole with the aid of water (patients may not chew, divide, dissolve, or crush the study medication)
• Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
• Patients with a current use or known history (over the past 6 months) of substance dependence
• Positive urine drug examination

Sponsors & Collaborators

• Janssen Pharmaceutica: 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

Results Point of Contact

• Title: Medical Affairs Director, CNS, Asia Pacific
• Organization: Janssen China

8610 5821 8766

Study Officials

• Janssen Pharmaceutica Clinical Trial

  Janssen Pharmaceutica

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 25, 2012
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 22, 2012
• Results First Posted: October 22, 2012

Record last verified: 2012-09