Schizophrenia, schizophreniform disorder, schizzoaffective disorder, psychotic NOS.
Conditions
Interventions
Trade Name: Prednisolone Mylan
Product Name: Prednisolone Mylan
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 50-24-8
Other descriptive name: PREDNISOLONE
Concentration uni
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A DSM-IV-TR diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or schizoaffective disorder) or 298.9 (psychosis NOS) 2. Onset of psychosis no longer than 7 years ago 3. Minimum total PANSS score of 60. 4. Age 18 -70 years. 5. Patients are treated with antipsychotic medication 6. Written informed consent is obtained 7. 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. 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
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 >30.0 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, defined as daily use during more than 2 months. Intermittent use is permitted, if stopped at least 1 month before start of treatment trial. 6. Pregnancy or breast-feeding. A urine pregnancy test will be performed at screening. 7. Concurrent use of certain types of medication: a. liver enzyme inducing medication such as carbamazepine, riphampicine, primidone, barbiturates and phenytoine b. HAART medication (both HIV protease inhibitors and (non)-nucleoside reverse transcriptase inhibitors), especially efavirenz, ritonavir and lopinavir. c. telaprevir and boceprevir in treatment of Hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Different lines of evidence now suggest that low grade inflammation in central lines of the central nervous system is involved in the pathogenesis of schizophrenia. Such inflamation could cause increased gray matter loss and consequently contribute to more severe negative and cognitive symptoms. We propose to investigate the effect of administering prednisolone ( a broad-acting, potent immune suppressive agent) versus placebo, psychotic symptoms, in addition to standard antipsychotical medication in patients with early stage schizophrenia or related disorders. This may prevent neural damage caused by low grade inflammatory processes in the brain. It is expected that symptom severity will be improved with prednisolone use. ;Secondary Objective: Secondary objectives concern the comparison of the 2 groups with regards to change in: -Positive and Negative Symptom Scale (PANSS) subscales. -Cognitive performance (Brief Assessment of Cognitive Functioning; BACS). -General functioning (Global Assessment of Functioning) -Depressive Symproms (Calgary Depression Scale for Schizophrenia) -Safety data will be evaluated by comparing indices of kay SAEs and SUSARs;Primary end point(s): Change in total score on the PANSS form baseline to end point (6 weeks assessment).;Timepoint(s) of evaluation of this end point: 6 weeks after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives concern the comparison of the 2 groups with regards to change in: -Change in total score on the PANSS form in follow-up -Positive and Negative Symptom Scale (PANSS) subscales. -Cognitive performance (Brief Assessment of Cognitive Functioning; BACS). -General functioning (Global Assessment of Functioning) -Depressive Symproms (Calgary Depression Scale for Schizophrenia) -Safety data will be evaluated by comparing indices of kay SAEs and SUSARs;Timepoint(s) of evaluation of this end point: 6, 16, 26 & 52 weeks after start treatment | — |
Countries
Belgium, Netherlands
Contacts
Public ContactDivision Neuroscience, Prednisolon
University Medical Center Utrecht
Outcome results
None listed