A Phase 2 interventional study of Prednisolone and Placebo in Schizophrenia and Related Disorders, Immune Suppression and Psychosis, sponsored by Haukeland University Hospital. Terminated at 3 sites in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-01.
Sponsored by Haukeland University Hospital · Phase 2, Interventional, and Treatment
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 with early-stage psychotic disorder. Secondary objectives include improvement of cognitive functioning and positive, negative and general psychopathological symptoms as well as general functioning.
Study design: Randomized placebo-controlled double-blind trial. Study population: 90 men and women, with an age of 18 years and older, diagnosed with schizophrenia spectrum disorder. The time interval between the onset of psychosis and study entry should not exceed five years and CRP level should be at least 3.9 mg/L.
Intervention: Patients will be randomized 1:1 to either prednisolone or placebo daily for a period of 6 weeks. Identical tablets will be administered. Prednisolone will be initiated at 40 mg for three days, after which it will be phased out within 6 weeks after start, following current treatment guidelines.
Main study parameters/endpoints: Primary outcome is change in symptom severity, expressed as a change in total score on the Positive and Negative Symptom Scale (PANSS) from baseline to end of the 6-week treatment. Secondary outcomes are a 6-month follow-up assessment of PANSS, cognitive functioning (measured through a repeatable neurocognitive battery, change in GAF scores and the measurement of various immunological biomarkers. In post-hoc analyses, attempts will be made to identify baseline blood markers with predictive properties regarding improvement in the anti-inflammatory drug treatment arm.
Expected benefits for consumers and care givers:
A decrease in symptom severity is expected, as low grade brain inflammation may be associated with psychotic symptoms. The results may give raise to a new line of scientific research as well as treatment options for a disabling disorder.
Exclusion Criteria:
Prednisolone tablets 5 mg
Drug: Prednisolone
Placebo tablets with identical appearance to the experimental drug.
Other: Placebo
Prednisolone tablets initiated at 40 mg for three days, after which it will be phased out within 6 weeks after start
Placebo tablets initiated at 40 mg for three days, after which it will be phased out within 6 weeks after start
Improvement of overall symptom severity
Overall symptom severity measured by the Positive and Negative Syndrome Scale. 30 items rated between 1 (symptom not present) and 7 (symptom present in the most severe degree. The sum score constitutes the overall symptom severity, and ranges between 30 - 210 Points.
Time frame: 6 weeks
Improvement of overall symptom severity after 6 and 12 months
Overall symptom severity measured by the Positive and Negative Syndrome Scale. 30 items rated between 1 (symptom not present) and 7 (symptom present in the most severe degree. The sum score constitutes the overall symptom severity, and ranges between 30 - 210 Points.
Time frame: 6 and 12 months
Improvement of overall cognition
Cognitive functioning as measured by the Brief Assessment of Cognition in Schizophrenia (BACS).
Time frame: 1 year
Improvement of positive symptoms
The Positive subscale score as measured by the Positive and Negative Syndrome Scale. 7 items rated between 1 (symptom not present) and 7 (symptom present in the most severe degree. The range is between 7-49 points
Time frame: 6 weeks, 6 months, 12 months
Improvement of negative symptoms
The Negative subscale score as measured by the Positive and Negative Syndrome Scale. 7 items rated between 1 (symptom not present) and 7 (symptom present in the most severe degree. The range is between 7-49 points
Time frame: 6 weeks, 6 months, 12 months
Improvement of general psychopathology
The general psychopathology subscale as measured by the Positive and Negative Syndrome Scale. 16 items rated between 1 (symptom not present) and 7 (symptom present in the most severe degree. The range is between 16-112 points
Time frame: 6 weeks, 6 months, 12 months
Improvement og the Global Assessment of Functioning scale (GAF)
GAF is scored between 1 (lowest possible functioning) and 100 (best possible functioning).
Time frame: 6 weeks, 6 months, 12 months
Change of depressive symptoms
Severity of depression is assessed using the Calgary Depression Scale for Schizophrenia, which has 9 items scored as 0 (symptom not present), 1 (mild degree), 2 (moderate degree), or 3 (severe degree of symptom). This makes a possible sub score range between 0 and 27).
Time frame: 6 weeks, 6 months, 12 months
Number of participants with treatment-related adverse events as assessed by the UKU Side Effects Rating Scale
Occurrence and severity of severe adverse events and suspected unexpected severe adverse reaction as measured by the UKU Side Effects Rating Scale.
Time frame: 12 months
Plan to share: No
This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Haukeland University Hospital