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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01947803
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : March 14, 2016
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Paliperidone Palmitate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Paliperidone Palmitate Drug: Paliperidone Palmitate
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 Measures :
  1. The Number of Patients Who Experienced Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Baseline, up to Week 29 ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: Baseline, Week 25 ]
    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).

  2. 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) [ Time Frame: Baseline, Week 25 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01947803

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Baoding, China
Beijing, China
Changsha, China
Chengdu, China
Guangzhou, China
Hangzhou, China
Kunming, China
Nanjing, China
Shijiazhuang, China
Taiyuan, China
Wuhan, China
Xian, China
Sponsors and Collaborators
Xian-Janssen Pharmaceutical Ltd.
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Study Director: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial Xian-Janssen Pharmaceutical Ltd.

Additional Information:
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Responsible Party: Xian-Janssen Pharmaceutical Ltd. Identifier: NCT01947803     History of Changes
Other Study ID Numbers: CR100855
R092670SCH4018 ( Other Identifier: Xi-an Janssen Pharmaceutical Ltd. )
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:

Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents