Long-acting Paliperidone Palmitate Injection and Olanzapine for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

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

Detailed description: 
      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
    

Intervention name(s): Olanzapine; Paliperidone
Intervention type(s): Drug; Drug
Intervention description(s): Olanzapine; Paliperidone
Intervention MeSH terms: Olanzapine; Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: schizophrenia; clinical trial; olanzapine; paliperidone