Long-acting Paliperidone Palmitate Injection and Olanzapine for Schizophrenia

Overview

A randomized trial of olanzapine and Long-acting paliperidone palmitate injection in the treatment of 100 treatment- naive first-episode patients with schizophrenia.

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. METHODS: 1. 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. 2. 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

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Outcomes