跳至主要内容
临床试验/NL-OMON46871
NL-OMON46871已完成不适用

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 30 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
niversitair Medisch Centrum Utrecht

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