Schizophrenia, schizophreniphorm disorder, schizoaffective disorder, psychosis NOS.
Conditions
Interventions
Trade Name: Prednisolon Alternova
Product Name: Prednisolon Alternova
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Helse-Bergen HF
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or schizoaffective disorder) or 298.9 (psychosis NOS) 2. Onset of psychosis no longer than 5 years ago 3. Minimum total PANSS score of 60 Age 18 -70 years. 4. Patients are treated with antipsychotic medication 5. Plasma level of CRP is > 3.9 mg/L at screening (through ‘high sensitivity’ measurement) 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 88 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study in case of: 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 >27.5 4. Current or chronic use of systemic glucocorticosteroids (temporary use is permitted, if stopped 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to investigate whether prednisolone improves overall symptom severity as compared to placebo when given for 3 days in a dosage of 40 mg and subsequently tapered during 6 weeks in addition to antipsychotic medication to patients with early-stage psychotic disorder. We expect to find an improvement of symptoms as measured by the Positive And Negative Syndrome Scale (PANSS) compared to baseline, over the course of 6 weeks (Kay et al., 1987).;Secondary Objective: Secondary objectives concern PANSS-scores after 6 and 12 months of follow up, improvement in cognitive functioning as measured by the Brief Assessment of Cognition in Schizophrenia (BACS). In addition, the positive and negative symptoms as well as general psychopathology (through PANSS subscales) are compared between treatment groups, next to general functioning using the GAF (Global Assessment of Functioning) (Karterud, 1998). Severity of depression will be assessed using the Calgary Depression Scale for Schizophrenia (CDSS) (Addington et al., 1990). Also the characteristics of patients (potentially) benefiting more from immunemodulation will be investigated through the assessment of a broad panel of immune parameters in blood. Finally, safety data will be evaluated by comparing incidences (number and % of subjects with at least one occurrence) of key SAEs and SUSARs between both groups, e.g. hospitalisations.;Primary end point(s): Primary endpoint is overall symptom severity as measured with the Positive and Negative Syndrome Scale (PANSS) total score (Kay et al., 1987). We will compare the effect of prednisolone versus placebo, both given in addition to antipsychotic medication, with regards to change in overall symptom severity;Timepoint(s) of evaluation of this end point: measured after 6 weeks of treatment compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study parameters include PANSS total scores 6 months after start of the treatment, neurocognitive functioning as measured with the Brief Assessment of Cognition in Schizophrenia (BACS) and symptom severity as measured with the PANSS subscales: the positive scale, negative scale and general psychopathology scale. Furthermore, general functioning will be evaluated using the split- GAF (Karterud, 1998). These parameters will be compared between patients treated with prednisolone versus placebo. Various serum and peripheral blood mononuclear cells will be collected from all patients at baseline, as well as after 3 and 6 weeks of treatment and after 6 months of follow up. Furthermore, severity of depression will be assessed and compared between groups using the CDSS. The need to adjust current antipsychotic medication with 25% or more of the dose in Defined Daily Doses (DDD) is compared between groups. Finally, safety data will be assessed by comparing incidences (number and % of subjects with at least one occurrence) of key SAEs and SUSARs between both groups, e.g. hospitalisations.;Timepoint(s) of evaluation of this end point: PANSS total scores 6 months after start of the treatment | — |
Countries
Norway
Contacts
Public ContactErik Johnsen
Helse Bergen HF
Outcome results
None listed