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Acetylsalicylic acid as an adjuvant therapy for schizophrenia
DOI 10.1186/ISRCTN27745631
ClinicalTrials.gov identifier
EudraCT number
Public title Acetylsalicylic acid as an adjuvant therapy for schizophrenia
Scientific title
Acronym Aspirine Trial
Serial number at source NTR29
Study hypothesis Findings from both epidemiological and basic research point to the possibility that non-steroidal anti-inflammatory drugs (NSAIDS) impede the deterioration in schizophrenia.
Lay summary
Ethics approval Ethics approval received from the Ethical Review Board of the University Medical Center Utrecht.
Study design Randomised, double blinded, placebo controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Schizophrenia, schizo-affective disorder, schizofreniform disorder
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 01/01/2004
Anticipated end date 01/09/2007
Status of trial Completed
Patient information material
Target number of participants 80
Interventions 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.

Acetylsalicylic acid 1000 mg versus placebo for 3 months (all receive daily pantoprazol 40 mg).
Primary outcome measure(s) Three-month change in positive and negative symptoms on the total PANSS score.
Secondary outcome measure(s) 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])
Sources of funding Stanley Medical Research Institute (USA)
Trial website
Publications 1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17059588
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20492850
Contact name Dr  Huib  Burger
  Address Department of Epidemiology and Bioinformatics
University Medical Center Groningen
P.O. Box 30001
  City/town Groningen
  Zip/Postcode 9700 AR
  Country Netherlands
  Email h.burger@epi.umcg.nl
Sponsor University Medical Centre Utrecht (UMCU) (Netherlands)
  Address P.O. Box 85500
  City/town Utrecht
  Zip/Postcode 3508 GA
  Country Netherlands
  Sponsor website: http://www.umcutrecht.nl/zorg/
Date applied 16/05/2005
Last edited 15/06/2010
Date ISRCTN assigned 16/05/2005
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