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ISRCTN
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ISRCTN27745631
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ClinicalTrials.gov identifier
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Public title
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Acetylsalicylic acid as an adjuvant therapy for schizophrenia
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Scientific title
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Acronym
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Aspirine Trial
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Serial number at source
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NTR29
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Study hypothesis
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Findings from both epidemiological and basic research point to the possibility that non-steroidal anti-inflammatory drugs (NSAIDS) impede the deterioration in schizophrenia.
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Lay summary
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Ethics approval
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Ethics approval received from the Ethical Review Board of the University Medical Center Utrecht.
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Study design
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Randomised, double blinded, placebo controlled, parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Schizophrenia, schizo-affective disorder, schizofreniform disorder
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Participants - inclusion criteria
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1. Schizophrenia, schizo-affective disorder, schizofreniform disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (for a maximum of 5 years) (as of 03/06/2008 this has been updated to a maximum of 10 years)
2. Aged 18 - 55 years
3. Stable
4. Minimum score of 60 on Positive and Negative Syndrome Scale (PANSS)
5. Minimum 2 x a score of minimum 4 on PANSS
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Participants - exclusion criteria
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1. No contra-indication for acetylsalicylic acid
2. No hypersensitivity to acetylsalicylic acid or pantoprazole
3. No significant somatic illness
4. No chronic use of a non-steroidal anti-inflammatory drug (NSAID)
5. No use of corticosteroids
6. Not pregnant
7. No drug dependency
8. Informed consent obtained
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Anticipated start date
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01/01/2004
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Anticipated end date
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01/09/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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80
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Interventions
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Please note that as of 03/06/2008 the anticipated end date of this trial has been updated to 01/09/2007, when this trial completed recruitment of participants. The previous anticipated end date of this trial was 01/01/2007.
Interventions:
Acetylsalicylic acid 1000 mg versus placebo for 3 months (all receive daily pantoprazol 40 mg).
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Primary outcome measure(s)
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Three-month change in positive and negative symptoms on the total PANSS score.
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Secondary outcome measure(s)
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1. Three-month change in the PANSS subscales
2. Cognitive symptoms
3. Immunological parameters (g-interferon, interleukin 4 [IL-4], interleukin 6 [IL-6] and interleukin 12 [IL-12])
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Sources of funding
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Stanley Medical Research Institute (USA)
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Trial website
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Publications
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1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17059588
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20492850
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Contact name
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Dr
Huib
Burger
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Address
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Department of Epidemiology and Bioinformatics
University Medical Center Groningen
P.O. Box 30001
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City/town
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Groningen
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Zip/Postcode
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9700 AR
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Country
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Netherlands
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Email
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h.burger@epi.umcg.nl
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Sponsor
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University Medical Centre Utrecht (UMCU) (Netherlands)
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Address
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P.O. Box 85500
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City/town
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Utrecht
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Zip/Postcode
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3508 GA
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Country
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Netherlands
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Sponsor website:
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http://www.umcutrecht.nl/zorg/
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Date applied
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16/05/2005
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Last edited
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15/06/2010
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Date ISRCTN assigned
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16/05/2005
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