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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685931
• Other study ID #: CR100880
• Secondary ID: R092670SCH4019
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2012
• Last updated: January 25, 2016
• Start date: November 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Xian-Janssen Pharmaceutical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 617
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Paliperidone Palmitate
One intramuscular injection of paliperidone palmitate flexible dose will be administered on Day 1, Day 8, and monthly thereafter.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xian-Janssen Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS)	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	No
Secondary	The change from baseline in Positive and Negative Syndrome Scale (PANSS) score	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	No
Secondary	The change from baseline in Clinical Global Impression - Severity (CGI-S)	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	No
Secondary	The change from baseline in Medication Satisfaction Questionnaire (MSQ)	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	No
Secondary	The change from baseline in Involvement Evaluation Questionnaire (IEQ)	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	No
Secondary	The change from baseline in Medication Adherence Rating Scale (MARS)	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	No
Secondary	The change from baseline in Medication Preference Questionnaire (MPQ)	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	No

External Links

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