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

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier:
NCT00686140
First received: June 10, 2006
Last updated: November 10, 2013
Last verified: November 2013
  Purpose

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 Intervention
Schizophrenia
Drug: celecoxib
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Beijing Hui-Long-Guan Hospital:

Primary Outcome Measures:
  • PANSS [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CGI [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • AIMS [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Cognition [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: June 2006
Study Completion Date: March 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686140

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

Additional Information:
No publications provided

Responsible Party: Xiang Yang Zhang, Director, Biological Psychiatry Center, Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier: NCT00686140     History of Changes
Other Study ID Numbers: 03T-459; SCH-A01, SMRI 03T-459
Study First Received: June 10, 2006
Last Updated: November 10, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Hui-Long-Guan Hospital:
Schizophrenia
clinical trial
risperidone
immune
celecoxib

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

ClinicalTrials.gov processed this record on September 22, 2014