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A Double-blind and Randomized Trial of Celecoxib Added to Risperidone in Treatment-naive First-episode Schizophrenia

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ClinicalTrials.gov Identifier: NCT00686140
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Schizophrenia Drug: celecoxib Drug: Placebo

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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in First-Episode and Drug-naive Patients With Schizophrenia
Study Start Date : June 2006
Primary Completion Date : December 2007
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Celecoxib, immune adjustor
Celecoxib
Drug: celecoxib
400mg/day, twice a day, 12 weeks
Other Name: Celebrex(R)
Placebo Comparator: Placebo
Placebo looks like the active drug celecoxib, with the same dose
Drug: Placebo
twice a day, 12 weeks


Outcome Measures

Primary Outcome Measures :
  1. PANSS [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. CGI [ Time Frame: 12 weeks ]
  2. AIMS [ Time Frame: 12 weeks ]
  3. Cognition [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686140


Locations
China
Beijing HuiLongGuan Hospital
Beijing, China, 100096
Sponsors and Collaborators
Beijing HuiLongGuan Hospital
Stanley Medical Research Institute
Investigators
Study Chair: Lian Y Cao, M.D. Beijing HuiLongGuan Hospital
More Information

Additional Information:
Responsible Party: Xiang Yang Zhang, Director, Biological Psychiatry Center, Beijing HuiLongGuan Hospital
ClinicalTrials.gov Identifier: NCT00686140     History of Changes
Other Study ID Numbers: 03T-459; SCH-A01
SMRI 03T-459 ( Other Grant/Funding Number: SMRI 03T-459 )
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Xiang Yang Zhang, Beijing HuiLongGuan Hospital:
Schizophrenia
clinical trial
risperidone
immune
celecoxib

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Celecoxib
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents