Status:
TERMINATED
The Norwegian Prednisolone in Early Psychosis Study
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
Helse Stavanger HF
St. Olavs Hospital
Conditions:
Schizophrenia and Related Disorders
Immune Suppression
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Objective: The primary objective of this trial is to investigate whether prednisolone improves symptom severity as compared to placebo when given in addition to antipsychotic medication to patients wi...
Eligibility Criteria
Inclusion
- A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or schizoaffective disorder) or 298.9 (psychosis NOS)
- Onset of psychosis no longer than 5 years ago
- Minimum total PANSS score of 60 Age 18 -70 years.
- Patients are treated with antipsychotic medication
- Written informed consent is obtained
- Female patients of childbearing potential need to utilize a proper method of contraception (the pill, vaginal ring, hormonal patch, intrauterine device, cervical cap, condom, contraceptive injection, diaphragm) in case of sexual intercourse during the study.
Exclusion
- Presence of any of the contra-indications of prednisolone as reported in the SPC. These include hypersensitivity to any ingredients in the formulation, systemic infections unless specific anti-infective therapy is employed, patients with ocular herpes simplex due to the possibility of perforation, recent vaccination with live or weakened virus or bacteria. Also the following special warnings in the SPC will represent exclusion criteria: Existing or previous history of severe affective disorders in themselves or in their first degree relatives, including depressive or bipolar disorders or previous steroid psychosis, glaucoma or family history of glaucoma, hypertension or heart failure, liver impairment and/ or failure, epilepsy, osteoporosis, peptic ulceration, previous steroid myopathy, renal insufficiency, history of tuberculosis or x-ray changes characteristic of tuberculosis, recent myocardial infarction, chickenpox, measles.
- Presence of diabetes mellitus or random (non-fasting) glucose levels exceeding 11 mmol/L at screening, or family history of diabetes.
- Body Mass Index (BMI) of \>30.0
- Current or chronic use of systemic glucocorticosteroids (temporary use is permitted, if stopped before start of treatment trial)
- Chronic use of non-steroidal anti-inflammatory drugs, defined as daily use during more than 2 months. Intermittent use is permitted, if stopped at least 1 month before start of treatment trial.
- Pregnancy or breast-feeding. A urine pregnancy test will be performed at screening and then after 6 weeks of treatment and the event of treatment discontinuation.
- Concurrent use of certain types of medication:
- 1\. liver enzyme inducing medication such as carbamazepine, riphampicine, primidone, barbiturates and phenytoine 2. HAART (both HIV protease inhibitors and (non)-nucleoside reverse transcriptase inhibitors), especially efavirenz, ritonavir and lopinavir.
- 3\. telaprevir and boceprevir in treatment of Hepatitis C
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03340909
Start Date
February 2 2018
End Date
December 31 2021
Last Update
August 1 2022
Active Locations (3)
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1
Haukeland University Hospital
Bergen, Norway
2
Stavanger University Hospital
Stavanger, Norway
3
St. Olavs Hospital
Trondheim, Norway