Prednisolone addition for patients with recent onset psychotic disorder: the role of immune-modulating strategies in the treatment of psychosis.

Completed

Conditions: psychotic disorder
schizophrenia
10007951
10039628

Registration Number: NL-OMON46871

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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 7 years ago.;3. Age 18-70 years.;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

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) of >30.0;4. Current or chronic use of systemic glucocorticosteroids (temporary use is permitted, if stopped 1 month before start of treatment trial);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 carbamazepine, riphampicine, primidone, barbiturates and phenytoine ;8. Concurrent use of HAART medication (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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in 'Positive and Negative Symptom Scale (PANSS)' total score compared to<br /><br>baseline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary objectives concern the comparison of the 2 groups with regards to<br /><br>changes in:<br /><br>- Positive and Negative Symptom Scale (PANSS) subscales<br /><br>- Cognitive performance (tested by the 'Brief assessment in cognition', BACS)<br /><br>- General functioning (tested by Global Assessment of Functioning, GAF)<br /><br>- Depressive symptoms (tested by Calgary Depression Scale for Schizophrenia)<br /><br>- Safety data will be evaluated by comparing incidences (number and % of<br /><br>subjects with at least one occurrence) of key SAEs and SUSARs (e.g.<br /><br>hospitalisations).<br /><br>- Changes in immune profile, measured by blood markers.</p><br>