Prednsiolone use next to standard treatment for patients with recent onset psychotic disorder: what is the effect of medication that affects the immune system?

Phase 1

Active, not recruiting

• Conditions: Schizophrenia, schizophreniphorm disorder, schizoaffective disorder, psychosis NOS.; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-000520-14-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-16
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 90

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 - 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

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.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified