Condition category
Mental and Behavioural Disorders
Date applied
16/05/2005
Date assigned
16/05/2005
Last edited
15/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Research organisation

Funder name

Stanley Medical Research Institute (USA)

Alternative name(s)

SMRI

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes