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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier:
NCT01685931
First received: September 11, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone Palmitate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Xian-Janssen Pharmaceutical Ltd.:

Primary Outcome Measures:
  • The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The change from baseline in Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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.

  • The change from baseline in Clinical Global Impression - Severity (CGI-S) [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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.

  • The change from baseline in Medication Satisfaction Questionnaire (MSQ) [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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).

  • The change from baseline in Involvement Evaluation Questionnaire (IEQ) [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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).

  • The change from baseline in Medication Adherence Rating Scale (MARS) [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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).

  • The change from baseline in Medication Preference Questionnaire (MPQ) [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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.


Enrollment: 617
Study Start Date: November 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685931

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
Sponsors and Collaborators
Xian-Janssen Pharmaceutical Ltd.
Investigators
Study Director: Xian-Janssen Pharmaceutical Ltd., China Clinical trial Xian-Janssen Pharmaceutical Ltd.
  More Information

No publications provided

Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01685931     History of Changes
Other Study ID Numbers: CR100880, R092670SCH4019
Study First Received: September 11, 2012
Last Updated: March 13, 2014
Health Authority: China: Ethics Committee

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Schizophrenia
Paliperidone Palmitate
Oral Antipsychotics
Invega Sustenna

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
9-hydroxy-risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 14, 2014