Prednisolone addition for atients 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.

niversity Medical Center Utrecht0 个研究点目标入组 90 人开始时间: 2014年7月16日最近更新: 2020年11月3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 7 years ago.
•3. Age 18 - 70years.
•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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.
•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 enzyminducing medication such as 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.

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