Acetylsalicylic acid as an adjuvant therapy for schizophrenia
| ISRCTN | ISRCTN27745631 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27745631 |
| Secondary identifying numbers | NTR29 |
- Submission date
- 16/05/2005
- Registration date
- 16/05/2005
- Last edited
- 15/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Huib Burger
Scientific
Scientific
Department of Epidemiology and Bioinformatics
University Medical Center Groningen
P.O. Box 30001
Groningen
9700 AR
Netherlands
| h.burger@epi.umcg.nl |
Study information
| Study design | Randomised, double blinded, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2004 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Epidemiology and Bioinformatics
Groningen
9700 AR
Netherlands
9700 AR
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Research organisation
Stanley Medical Research Institute (USA)
Private sector organisation / Research institutes and centers
Private sector organisation / Research institutes and centers
- Alternative name(s)
- The Stanley Medical Research Institute, SMRI
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/10/2006 | Yes | No | |
| Results article | results | 01/05/2010 | Yes | No |
