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A Safety and Effectiveness Study of Paliperidone Palmitate in Chinese Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Paliperidone Palmitate

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone, Safety, Effectiveness, Chinese

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent to participate in the study obtained -
Confirmation of diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) within 5 years prior to screening
Patient is willing and able to fill out self-administered questionnaires during the study
confirmation that patient has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time before enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication

Exclusion Criteria:

The patient's psychiatric diagnosis is due to the direct pharmacological effects of a drug of abuse substance or medication, or is due to a general medical condition (eg, clinically notable hypothyroidism)
The patient is treatment resistant in the judgment of the investigator
The patient meets the DSM-IV definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry
The patient has a previously defined hypersensitivity (anaphylaxis-type reaction) to risperidone or paliperidone or excipients
The patient has received treatment with a long-acting injectable antipsychotic within 3 injection cycles prior to baseline, received clozapine within 3 months prior to screening, received treatment with other investigational agents within 30 days of the screening visit, has participated in more than one investigational drug study in the past 12 months, or has planned use of other investigational drugs during the time frame of the study
History or current symptoms of tardive dyskinesia, history of neuroleptic malignant syndrome, or evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in the past 6 months

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paliperidone Palmitate

Arm Description

Outcomes

Primary Outcome Measures

The Number of Patients Who Experienced Adverse Events as a Measure of Safety and Tolerability

Secondary Outcome Measures

Changes in Positive and Negative Syndrome Scale (PANSS) total scores from baseline at each visit between groups or subgroups (with psychiatry history <=5 years or >5 years)

PANSS is used for measuring symptom severity of patients with schizophrenia. PANSS includes a total score (sum of 30 items) and 3 subscale scores including positive subscale (7 items), Negative subscale (7 items) and General psychopathology subscale (16 items). The rank of each scale is rated from 1 point (absent) to 7 points (extreme).

Changes in Personal and Social Performance (PSP) Scale Scores from Baseline at Each Visit Between Groups or Subgroups (with Psychiatry History <=5 years or >5 years)

PSP scale is used for evaluation of a patient's personal and social functions. PSP is used for degrees of difficulties on four functioning dimensions during previous 1 month: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behaviors. Every dimension is rated (i. absent to vi. very severe). PSP total scores range from 1-100, which are divided into 10 ratings to assess difficulties degrees. Ratings from 71-100 reflect only mild difficulties; ratings from 31-70 reflect manifest disabilities of various degrees; ratings ≤30 reflect functioning so poor that intensive support or supervision is needed.

Full Information

NCT ID

NCT01947803

First Posted

September 17, 2013

Last Updated

March 11, 2016

Sponsor

Xian-Janssen Pharmaceutical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01947803

Brief Title

A Safety and Effectiveness Study of Paliperidone Palmitate in Chinese Patients With Schizophrenia

Official Title

Safety and Effectiveness of Paliperidone Palmitate in 25-week Treatment on Chinese Patients With Schizophrenia: an Open-label, Single-arm, Multicenter Prospective Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xian-Janssen Pharmaceutical Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study will be to evaluate the safety and treatment response of paliperidone palmitate administered to Chinese patients with schizophrenia.

Detailed Description

This study is a single-group, open-label (name of study drug is known to patients), multicenter study to evaluate the safety and efficacy/treatment response of paliperidone palmitate administered for 25 weeks as once-monthly injections to Chinese patients with schizophrenia who previously received treatment with oral antipsychotic medications. A target of 353 patients (inpatients or outpatients) with schizophrenia will be enrolled in the study and will receive injections of study drug (paliperidone palmitate) on Days 1 and 8, and thereafter at a monthly flexible dose, based on patients' tolerability and/or efficacy. The study will consist of a screening period of up to 1 week before treatment, a 25-week treatment period, and a follow-up period approximately 30 days after the last injection of study drug. Upon meeting the entry criteria for the study, patients will receive a total of 8 intramuscular (IM) injections of paliperidone palmitate during the treatment period as follows: 150 mg equivalent (eq) on Day 1, 100 mg eq on Day 8, and subsequent monthly IM injections with a flexible dose range of 75-150 mg eq. If the patient reports any signs or symptoms of worsening of schizophrenia, the investigator may prescribe a rescue medication (quick-relief or fast-acting medications that usually work right away to relieve symptoms) such as lorazepam (an antianxiety drug) to control agitation, irritability, restlessness, and hostility. Safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Schizophrenia, Paliperidone, Safety, Effectiveness, Chinese

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

353 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paliperidone Palmitate

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Paliperidone Palmitate

Intervention Description

Paliperidone Palmitate is injected with a dose of 150 mg eq. on Day 1 and 100 mg eq. on Day 8 in the deltoid muscle, followed by a monthly flexible dose range of 75 - 150 mg eq. for injection, based on patients' tolerability and/or efficacy. Monthly doses can be administered in either the deltoid or gluteal muscle alternatively. All the antipsychotics should be discontinued prior to the first dose of study drug. Other antipsychotics are prohibited across this study.

Primary Outcome Measure Information:

Title

The Number of Patients Who Experienced Adverse Events as a Measure of Safety and Tolerability

Time Frame

Baseline, up to Week 29

Secondary Outcome Measure Information:

Title

Changes in Positive and Negative Syndrome Scale (PANSS) total scores from baseline at each visit between groups or subgroups (with psychiatry history <=5 years or >5 years)

Description

Time Frame

Baseline, Week 25

Title

Changes in Personal and Social Performance (PSP) Scale Scores from Baseline at Each Visit Between Groups or Subgroups (with Psychiatry History <=5 years or >5 years)

Description

Time Frame

Baseline, Week 25

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent to participate in the study obtained - Confirmation of diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) within 5 years prior to screening Patient is willing and able to fill out self-administered questionnaires during the study confirmation that patient has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time before enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication Exclusion Criteria: The patient's psychiatric diagnosis is due to the direct pharmacological effects of a drug of abuse substance or medication, or is due to a general medical condition (eg, clinically notable hypothyroidism) The patient is treatment resistant in the judgment of the investigator The patient meets the DSM-IV definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry The patient has a previously defined hypersensitivity (anaphylaxis-type reaction) to risperidone or paliperidone or excipients The patient has received treatment with a long-acting injectable antipsychotic within 3 injection cycles prior to baseline, received clozapine within 3 months prior to screening, received treatment with other investigational agents within 30 days of the screening visit, has participated in more than one investigational drug study in the past 12 months, or has planned use of other investigational drugs during the time frame of the study History or current symptoms of tardive dyskinesia, history of neuroleptic malignant syndrome, or evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in the past 6 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

Organizational Affiliation

Xian-Janssen Pharmaceutical Ltd.

Official's Role

Study Director

Facility Information:

City

Baoding

Country

China

City

Beijing

Country

China

City

Changsha

Country

China

City

Chengdu

Country

China

City

Guangzhou

Country

China

City

Hangzhou

Country

China

City

Kunming

Country

China

City

Nanjing

Country

China

City

Shijiazhuang

Country

China

City

Taiyuan

Country

China

City

Wuhan

Country

China

City

Xian

Country

China

12. IPD Sharing Statement

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=3523&filename=CR100855_CSR.pdf

Description

Safety and Efficacy of Paliperidone Palmitate in 25-week Treatment on Chinese Patients with Schizophrenia: an Open-label, Single-arm, Multicenter Prospective Study

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A Safety and Effectiveness Study of Paliperidone Palmitate in Chinese Patients With Schizophrenia

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