NCT00686140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

June 10, 2006

Last Update Submit

July 10, 2016

Conditions

Schizophrenia

Keywords

Schizophreniaclinical trialrisperidoneimmunecelecoxib

Outcome Measures

Primary Outcomes (1)

  • PANSS

    12 weeks

Secondary Outcomes (3)

  • CGI

    12 weeks

  • AIMS

    12 weeks

  • Cognition

    12 weeks

Study Arms (2)

Celecoxib, immune adjustor

EXPERIMENTAL

Celecoxib

Drug: celecoxib

Placebo

PLACEBO COMPARATOR

Placebo looks like the active drug celecoxib, with the same dose

Drug: Placebo

Interventions

celecoxibDRUG

400mg/day, twice a day, 12 weeks

Also known as: Celebrex(R)
Celecoxib, immune adjustor
PlaceboDRUG

twice a day, 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing HuiLongGuan Hospital

Beijing, 100096, China

Location

Related Publications (1)

  • Wang DM, Chen DC, Xiu MH, Wang L, Kosten TR, Zhang XY. A double-blind, randomized controlled study of the effects of celecoxib on clinical symptoms and cognitive impairment in patients with drug-naive first episode schizophrenia: pharmacogenetic impact of cyclooxygenase-2 functional polymorphisms. Neuropsychopharmacology. 2024 Apr;49(5):893-902. doi: 10.1038/s41386-023-01760-8. Epub 2023 Oct 30.

    PMID: 37903861DERIVED

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lian Y Cao, M.D.

    Beijing HuiLongGuan Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Biological Psychiatry Center

Study Record Dates

First Submitted

June 10, 2006

First Posted

May 29, 2008

Study Start

June 1, 2006

Primary Completion

December 1, 2007

Study Completion

March 1, 2008

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

CN(1)