Acetylsalicylic acid as an adjuvant therapy for schizophrenia

ISRCTN	ISRCTN27745631
DOI	https://doi.org/10.1186/ISRCTN27745631
Protocol serial number	NTR29
Sponsor	University Medical Centre Utrecht (UMCU) (Netherlands)
Funder	Stanley Medical Research Institute (USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Huib Burger
Scientific

Department of Epidemiology and Bioinformatics
University Medical Center Groningen
P.O. Box 30001
Groningen
9700 AR
Netherlands

Email	h.burger@epi.umcg.nl

Primary study design	Interventional
Study design	Randomised, double blinded, placebo controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Aspirine Trial
Study objectives	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(s)	Ethics approval received from the Ethical Review Board of the University Medical Center Utrecht.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Acetylsalicylic acid, pantoprazol
Primary outcome measure(s)	Three-month change in positive and negative symptoms on the total PANSS score.
Key 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])
Completion date	01/09/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	01/01/2004
Date of final enrolment	01/09/2007

Department of Epidemiology and Bioinformatics

Groningen
9700 AR
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2010		Yes	No
Protocol article	protocol	23/10/2006		Yes	No