Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia

NCT01662648 | Completed Phase 3 Results

• 2 other identifiers: CR013534R076477SCH3024
• Study Type: interventional
• Target: 1,117
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to explore the efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were previously unsuccessfully treated with other oral antipsychotics.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone; Paliperidone extended-release (ER)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26

  The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.

  Baseline and Week 26

Secondary Outcomes (8)

• Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26

  Week 26

• Change From Baseline in PANSS Total Positive Subscale Score at Week 26

  Baseline and Week 26

• Change From Baseline in PANSS Total Negative Subscale Score at Week 26

  Baseline and Week 26

• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26

  Baseline and Week 26

• Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26

  Baseline and Week 26

Study Arms (2)

Paliperidone ER: Lack of efficacy

EXPERIMENTAL

Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.

Drug: Paliperidone ER

Paliperidone ER: Lack of tolerability, compliance or other

EXPERIMENTAL

Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.

Drug: Paliperidone ER

Interventions

Paliperidone ER DRUG

Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion.

Paliperidone ER: Lack of efficacy; Paliperidone ER: Lack of tolerability, compliance or other

Eligibility Criteria

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

You may qualify if:

• Participant diagnosed with schizophrenia
• Participant's previous treatment of schizophrenia is considered unsuccessful
• Participant is healthy on the basis of a physical examination and vital signs
• Women must be postmenopausal, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
• Be willing and able to fill out self-administered questionnaires

You may not qualify if:

• Have used clozapine or Risperdal CONSTA during the last month, or have received any other conventional drug used to treat psychosis during the last 3 months
• 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
• Pregnant or breast-feeding female
• History or current symptoms of tardive dyskinesia (involuntary movements of the facial muscles and tongue)

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: Regional Medical Franchis Director AP
• Organization: Janssen China

+86 10 582 187 66

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 10, 2012
• Study Start: June 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2009
• Last Updated: May 5, 2014
• Results First Posted: March 26, 2014

Record last verified: 2014-04