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Acetylsalicylic acid as an adjuvant therapy for schizophrenia.


- candidate number0
- NTR NumberNTR29
- ISRCTNISRCTN27745631
- Date ISRCTN created16-mei-2005
- date ISRCTN requested12-apr-2005
- Date Registered NTR22-dec-2004
- Secondary IDsN/A 
- Public TitleAcetylsalicylic acid as an adjuvant therapy for schizophrenia.
- Scientific TitleAcetylsalicylic acid as an adjuvant therapy for shizophrenia.
- ACRONYMAspirine Trial
- hypothesisFindings from both epidemiological and basic research point to the possibility that NSAIDS impede the deterioration in schizophrenia.
- Healt Condition(s) or Problem(s) studiedSchizophrenia, Schizophreniform disorder, Schizoaffective disorder
- Inclusion criteria1. Schizophrenia
2. Schizo-affective disorder
3. Schizofreniform disorder according to DSM-IV (for max 10 years)
4. Age 18 - 55 years
5. Stabile, min. 60 on PANSS, min 2x a score of min 4 on PANSS.
- Exclusion criteria1. No contraindication for acetylsalicylic acid
2. No hypersensitivity to acetylsalicylic acid or pantoprazole
3. No significant somatic illness
4. No chronic use of a nonsteroidal anti-inflammatory drug (NSAID)
5. No use of corticosteroids
5. Not pregnant
6. No drugs dependency
7. Informed consent obtained.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-2004
- planned closingdate1-jan-2007
- Target number of participants80
- InterventionsAcetylsalicylacid 1000mg vs Placebo for 3 months (All daily pantoprazol 40 mg).
- Primary outcome3-month change in positive and negative symptoms on the total PANSS score.
- Secondary outcome3-month change in the PANSS subscales, cognitive symptoms, immunological parameters (g-interferon, IL-4, IL-6 and IL-12).
- Timepoints
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. PhD. H. Burger
- CONTACT for SCIENTIFIC QUERIESMD. PhD. H. Burger
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
The Stanley Medical Research Institute (http://www.stanleyresearch.org/)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD5-jul-2005 - 31-mei-2008


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