Long-acting Paliperidone Palmitate Injection and Olanzapine for Schizophrenia
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|ClinicalTrials.gov Identifier: NCT02918825|
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Olanzapine Drug: Paliperidone||Not Applicable|
OBJECTIVE: Investigator compared the efficiency, social function, cognitive function and side effect of olanzapine and Long-acting paliperidone palmitate injection in the treatment of first-episode drug-naive patients with schizophrenia.
- Clinical Trial: This is a randomized trial in treatment-naive first-episode patients with schizophrenia. The study consists of a 1-week stabilization phase, followed by 12 weeks of treatment. The total trial duration is 13 weeks.
- Assessment Procedures:
2.1. Primary Outcome Variable-psychopathology: Assessment instruments include the Positive and Negative Syndrome Scale (PANSS), the Assessment of Negative Symptoms (SANS) and the Clinical Global Impression (ICG). Patients are interviewed at screening, at week-4, at week-1, at baseline and at every two weeks, for a total of 12 ratings.
2.2. Cognitive tests: A comprehensive battery of tests encompassing the cognitive domains of executive function, attention, memory, perception, and general intellect is administered twice at baseline and at the end of 16-week treatment by a trained psychologist. Scoring follows standardized procedures. The Wisconsin Card Sorting Test (WCST) is administered as a measure of executive function. The N-back (0-3 back) test is administered as a measure of working memory. Logical Memory I and II, Verbal Paired Associates I and II, Visual Reproduction I and II and Digits Forward from the Wechsler Memory Scale-Revised (WMS-R) are administered as a tests of episodic memory. The Distractibility version of Gordon Continuous Performance Test (CPT)is administered as a test of attention. A four-subtest version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R), consisting of the Arithmetic, Similarities, Picture Completion, and Digit Symbol Substitution tests is administered to obtain an estimate of current Full- Scale Intelligence Quotient (FSIQ).
2.3. Social functioning: The Personal and Social Performance Scale (PSP) examines the four dimensions of social functioning: Socially useful activities including work and study, personal and social relationships, self-care, disturbing and aggressive behaviors.
2.4. Side Effects: Parkinsonism is rated with the Simpson-Angus Scale for extrapyramidal side effects (SAS). The Abnormal Involuntary Movement Scale (AIMS) is chosen to assess tardive dyskinesia (TD) severity. All of the AIMS and Simpson-Angus Rating Scales are administered by the same investigator, at screening, at week-4, at week-1, at baseline and at baseline and at every two weeks, for a total of 12 ratings.
2.5.Weight gain measurement: weight gain every week 2.6. Serum measurement: triglyceride, blood sugar，cholesterol，blood pressure
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Trial to Compare the Efficiency and Side Effect Between Olanzapine and Long-acting Paliperidone Palmitate Injection in Schizophrenia|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||August 30, 2017|
|Actual Study Completion Date :||September 30, 2017|
Drug: Paliperidone, 75-150mg/month, once a month, 12 weeks
Active Comparator: Olanzapine
Drug: Olanzapine, 20mg/day, twice a day, 12 weeks
- Symptoms assessed on PANSS. [ Time Frame: 12 weeks ]Clinical symptoms
- Clinical global impression assessed on CGI. [ Time Frame: 12 weeks ]clinical severity
- Cognitive functioning assessed on RBANS. [ Time Frame: 12 weeks ]cognitive performance
- Number of weight change in treatment assessed on Weight gain. [ Time Frame: 12 weeks ]weight gain
- Abnormal Involuntary Movement Scale assessed Abnormal Involuntary Movement Scale assessed on AIMS. [ Time Frame: 12 weeks ]Side effects
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): NCT02918825
|Beijing HuiLongGuan Hospital|
|Beijing, China, 100096|
|Principal Investigator:||Xiang Zhang, MD, PhD||The University of Texas Health Science Center, Houston|