A Safety and Effectiveness Study of Paliperidone Palmitate in Chinese Patients With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT01947803|
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : March 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Paliperidone Palmitate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||353 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- The Number of Patients Who Experienced Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Baseline, up to Week 29 ]
- 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).
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01947803
|Study Director:||Xian-Janssen Pharmaceutical Ltd., China Clinical Trial||Xian-Janssen Pharmaceutical Ltd.|