psychotisch disorder schizophrenia
Conditions
Interventions
The main investigational product used in this trial is prednisolone, which is
approved for systemic treatment for disorders such as rheumatical, pulmonal,
gastrointestinal, endocrinological, hematol
during the first week patients will use 30 mg per
day. In each following week, the dose will be decreased with 5 mg, so patients
will use 5 mg per day in week 6. After this week they can stop using
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. DSM-IV-R diagnosis of 295.x (schizophrenia, schizophreniform or schizoaffective disorder) or 298.9 (psychosis NOS). 2. Start of first psychosis no longer than 3 years ago. 3. Age 18 years or older. 4. Patients use a stable dosis of antipsychotic medication for at least 3 weeks. 5. Written informed consent is obtained. 6. Female patients of childbearing potential need to utilize a proper method of contraception in case of sexual intercourse during the study.
Exclusion criteria
Exclusion criteria: 1. Presence of any of the contra-indications of prednisolone as reported in the SPC. 2. Presence of diabetes mellitus or random (non-fasting) glucose levels exceeding 11 mmol/L at screening, severe heart failure, severe osteoporosis or systemic fungal infections. 3. Body Mass Index (BMI) higher than 27.5 4. Current or chronic use of glucocorticosteroids or other steroids 5. Chronic use of non-steroidal anti-inflammatory drugs (2 months or more of continuous use) 6. Pregnancy or breast-feeding. 7. Concurrent use of enzyminducing medication such as carbamazepine, riphampicine, primidone, barbiturates and phenytoine 8. Concurrent use of HAART (both HIV protease inhibitors and (non)-nucleoside reverse transcriptase inhibitors), especially efavirenz, ritonavir and lopinavir 9. Current use of telaprevir and boceprevir in treatment of Hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Positive and Negative Symptom Scale (PANSS) total score compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives concern the comparison of the 2 groups with regards to changes in: - Positive and Negative Symptom Scale (PANSS) subscales. - cognitive performance (BACS) - General functioning (Global Assessment of Functioning) - depressive symptoms (Calgary Depression Scale for Schizophrenia) - safety data will be evaluated by comparing incidences (number and % of subjects with at least one occurrence) of key SAEs and SUSARs (e.g. hospitalisations) | — |
Countries
Netherlands
Outcome results
None listed