Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in First-Episode and Drug-naive Patients With Schizophrenia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Beijing HuiLongGuan Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- PANSS
Study Overview
Brief 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:
- 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.
- 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of schizophrenia or schizophreniform disorder;
- •Duration of symptoms not longer than 60 months;
- •No prior treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days;
- •Between 16 and 40 years of age; and
- •Current psychotic symptoms of moderate severity.
Exclusion Criteria
- •A DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform;
- •Documented disease of the central nervous system that can interfere with the trial assessments including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic, infection;
- •Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension);
- •A clinically significant ECG abnormality in the opinion of the investigator;
- •Pregnant or breast-feeding female;
- •Use of disallowed concomitant therapy;
- •History of severe allergy or hypersensitivity.
Arms & Interventions
Celecoxib, immune adjustor
Celecoxib
Intervention: celecoxib (Drug)
Placebo
Placebo looks like the active drug celecoxib, with the same dose
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
PANSS
Time Frame: 12 weeks
Secondary Outcomes
- AIMS(12 weeks)
- CGI(12 weeks)
- Cognition(12 weeks)
Investigators
Xiang Yang Zhang
Director, Biological Psychiatry Center
Beijing HuiLongGuan Hospital