A Double-blind and Randomized Trial of Celecoxib Added to Risperidone in Treatment-naive First-episode Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      A double-blind, randomized, placebo-controlled trial of celecoxib as an add-on therapy to
      risperidone compared to risperidone plus placebo in the treatment of 200 treatment-naive
      first-episode patients with schizophrenia. The study addresses an immune dysfunction
      hypothesis of schizophrenia.
    

Detailed description: 
      OBJECTIVE: Evidences of high levels of activating cytokines in the CSF and signs of CNS
      inflammation have suggested that an inflammatory/immunological pathogenesis may exist in a
      subgroup of schizophrenic patients. We hypothesize that anti-inflammatory therapy by using an
      add-on agent together with a well-proven neuroleptic may have favorable effects on some
      schizophrenic patients.

      METHODS:

        1. Clinical Trial: This is a randomized, double-blind and parallel controlled trial in
           treatment-naive first-episode patients with schizophrenia. The study consists of a
           1-week stabilization phase, followed by 12 weeks of double-blind 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) (Kay et al, 1987), the Assessment of Negative Symptoms
      (SANS) (Andreasen 1981) 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) (Heaton et al, 1993)
      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) (Wechsler, 1987) 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), (Wechsler, 1981; Missar et al, 1994) 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. Side Effects: Parkinsonism is rated with the Simpson-Angus Scale for extrapyramidal side
      effects (SAS, Simpson and Angus, 1970). The Abnormal Involuntary Movement Scale (AIMS) (Guy,
      1978) 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.

      2.4.Serum Measures: IL-2, IL-6, IL-8 and IL-10 concentrations
    

Intervention name(s): celecoxib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400mg/day, twice a day, 12 weeks; twice a day, 12 weeks
Other intervention name(s): Celebrex(R)
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; clinical trial; risperidone; immune; celecoxib