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

Phase 3

Withdrawn

Conditions: schizophrenia
psychotisch disorder
10007951
10039628

Registration Number: NL-OMON38677

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 70

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

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

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>Secondary 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 (BACS)<br /><br>- General functioning (Global Assessment of Functioning)<br /><br>- depressive symptoms (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)</p><br>