The effect of prednisolone on symptom severity in schizophrenia: A placebo-controlled, randomized controlled trial

Abstract

Objective: Immune dysregulation may be involved in the pathophysiology of schizophrenia. Given the need for new treatment options in schizophrenia, anti-inflammatory medication could be a potential treatment in this illness. Methods: In this double-blind, placebo-controlled clinical trial, patients with schizophrenia, schizoaffective disorder or psychosis NOS were randomized 1:1 to either prednisolone or placebo, in addition to their regular antipsychotic medication. Patients diagnosed with schizophrenia for less than 7 years and on antipsychotics, were treated with prednisolone or placebo, tapered-off within six weeks in the following schedule: 40 mg/day for 3 days and 30 mg/day for 4 days, followed by a decrease of 5 mg/day per week during the remaining 5 weeks. Change in symptom severity relative to baseline was compared between treatment arms, as measured through the Positive and Negative Syndrome Scale total score. Results: In total, 68 patients signed informed consent and were screened on eligibility criteria, of whom 42 patients were randomized to either prednisolone or placebo, with 39 patients completing the treatment and tapering phase. Due to recruitment difficulties, the study was terminated prematurely. Symptom severity decreased significantly in both the prednisone and placebo treatment arm (p < 0.001). The degree of improvement was not significantly different between treatment arms (p = 0.96). No serious adverse events occurred during the treatment phase. Discussion: There is no indication that prednisolone has a beneficial effect on symptom severity, as adjunctive treatment in patients with schizophrenia, as compared to placebo. Conclusion: Adjunctive treatment with prednisolone did not improve symptom severity compared to placebo in patients with schizophrenia.