Schizophrenia Clinical Trial
Official title:
A Randomized Trial to Compare the Efficiency and Side Effect Between Olanzapine and Long-acting Paliperidone Palmitate Injection in Schizophrenia
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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