Contact information
Type
Scientific
Primary contact
Dr Huib Burger
ORCID ID
Contact details
Department of Epidemiology and Bioinformatics
University Medical Center Groningen
P.O. Box 30001
Groningen
9700 AR
Netherlands
h.burger@epi.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR29
Study information
Scientific title
Acronym
Aspirine Trial
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Schizophrenia, schizo-affective disorder, schizofreniform disorder
Intervention
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).
Intervention type
Drug
Phase
Not Specified
Drug names
Acetylsalicylic acid, pantoprazol
Primary outcome measure
Three-month change in positive and negative symptoms on the total PANSS score.
Secondary outcome measures
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])
Overall trial start date
01/01/2004
Overall trial end date
01/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant 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
Recruitment start date
01/01/2004
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Epidemiology and Bioinformatics
Groningen
9700 AR
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (Netherlands)
Sponsor details
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Stanley Medical Research Institute (USA)
Alternative name(s)
The Stanley Medical Research Institute, SMRI
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17059588
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20492850
Publication citations
-
Protocol
Laan W, Selten JP, Kahn RS, Huisman AM, Heijnen CJ, Grobbee DE, Burger H, Acetylsalicylic acid as an adjuvant therapy for schizophrenia., Trials, 2006, 7, 31, doi: 10.1186/1745-6215-7-31.
-
Results
Laan W, Grobbee DE, Selten JP, Heijnen CJ, Kahn RS, Burger H, Adjuvant aspirin therapy reduces symptoms of schizophrenia spectrum disorders: results from a randomized, double-blind, placebo-controlled trial., J Clin Psychiatry, 2010, 71, 5, 520-527, doi: 10.4088/JCP.09m05117yel.