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

niversitair Medisch Centrum Utrecht0 个研究点目标入组 70 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•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.

•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

发起方

niversitair Medisch Centrum Utrecht