A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics

January 25, 2016 updated by: Xian-Janssen Pharmaceutical Ltd.

Effectiveness, Safety and Tolerability of Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics and With Acute Symptom of Schizophrenia: A 13-Week, Open-label, Single-arm, Multicenter, Prospective, Interventional Study Followed by a Naturalistic Additional 1 Year Follow up

The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated by oral antipsychotics and with acute symptom of schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a 13-week, open-label (all people know the identity of the intervention), single-arm (one group of patients), multicenter, prospective, interventional study in Chinese patients. In a prospective, interventional study, the patients identified receive a treatment during the course of the research study and are followed forward in time for the outcome of the study. In China, there is still insufficient information about effectiveness, tolerability, and dosage strategy for directly switching from previous oral antipsychotics (drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders) in patients with acute symptoms. Acute symptoms are quick and severe form of illness in its early stage. In addition, there is also lack of information about bridging acute phase to long-term treatment. In this study, patients with multiple types of acute schizophrenia will be recruited and will receive Sustenna (paliperidone palmitate) treatments for 13 weeks. After the acute treatment, the patients will continue to receive the prescribed medication and will be followed up for an additional 52 weeks to assess the outcomes related to long-term treatment.

Study Type

Interventional

Enrollment (Actual)

617

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Baoding, China
      • Beijing, China
      • Chengdu, China
      • Chongqing, China
      • Fuzhou, China
      • Guangzhou, China
      • Hangzhou, China
      • Jinan, China
      • Nanjing, China
      • Qingdao, China
      • Shantou, China
      • Shenzhen, China
      • Shijiazhuang, China
      • Suzhou, China
      • Taiyuan, China
      • Tianjin, China
      • Wuhan, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous diagnosis of schizophrenia
  • Experiencing an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120, inclusive
  • Patients currently treated with antipsychotic are allowed to be recruited
  • Be medically stable on the basis of clinical laboratory tests performed at screening

Exclusion Criteria:

  • A primary diagnosis other than schizophrenia
  • History of risperidone or paliperidone resistance as defined by failure to respond to 2 adequate treatment periods
  • Clozapine use for treatment refractory schizophrenia
  • Relevant history or current presence of any significant or unstable condition, disease or illness that could limit the participation in the study according to the investigator
  • Woman who is pregnant, breast-feeding, or is planning to become pregnant within 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paliperidone Palmitate
Drug: Paliperidone Palmitate
One intramuscular injection of paliperidone palmitate flexible dose will be administered on Day 1, Day 8, and monthly thereafter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS)
Time Frame: Baseline, Week 13
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, Week 13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change from baseline in Positive and Negative Syndrome Scale (PANSS) score
Time Frame: Baseline, Week 13
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, Week 13
The change from baseline in Clinical Global Impression - Severity (CGI-S)
Time Frame: Baseline, Week 13
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 patient. 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 patients". Higher scores indicate worsening.
Baseline, Week 13
The change from baseline in Medication Satisfaction Questionnaire (MSQ)
Time Frame: Baseline, Week 13
The MSQ is a 7-point, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied or Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Baseline, Week 13
The change from baseline in Involvement Evaluation Questionnaire (IEQ)
Time Frame: Baseline, Week 13
The IEQ is a 31-item questionnaire that assesses the encouragement and care that the caregiver has to give to the patient, to personal problems between patient and caregiver, and to the caregiver's worries, coping and subjective burden. All items are scored on 5-point Likert scales (never, sometimes, regularly, often, always).
Baseline, Week 13
The change from baseline in Medication Adherence Rating Scale (MARS)
Time Frame: Baseline, Week 13
The MARS is a ten-item yes/no self-report measure of medication adherence in psychosis. Total scores range from 0 (low likelihood of medication adherence) to 10 (high likelihood of medication adherence).
Baseline, Week 13
The change from baseline in Medication Preference Questionnaire (MPQ)
Time Frame: Baseline, Week 13
The MPQ is used to investigate which treatment (oral or injection) the patients prefer and why they prefer this treatment, and to investigate which injectable site (deltoid or gluteal) they prefer and why they prefer this treatment.
Baseline, Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xian-Janssen Pharmaceutical Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 14, 2012

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100880
  • R092670SCH4019 (Other Identifier: Xian-Janssen Pharmaceutical Ltd., China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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