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Prednisolone add-on in early phase schizophrenia: A randomized, double-blind, placebo-controlled pilot study
Gunnhild E Hoprekstad1,2,3, Erik Johnsen1,2,3, Christoffer Bartz-Johannessen1,3
1Division of Psychiatry, Haukeland University Hospital, Bergen, Norway.
Brain, Behavior, & Immunity - Health
|July 29, 2025
Summary
Add-on prednisolone showed a trend towards reducing psychotic symptoms in schizophrenia patients. Further research is needed to confirm these findings and explore the underlying mechanisms of action.
Area of Science:
- Psychiatry
- Immunology
- Pharmacology
Background:
- Current schizophrenia treatments have limitations in efficacy and tolerability.
- Aberrant immune system activity is implicated in schizophrenia, but translation to treatment is pending.
- Potent anti-inflammatory agents like prednisolone may offer a novel therapeutic approach.
Purpose of the Study:
- To investigate the efficacy of prednisolone as an add-on therapy for schizophrenia.
- To establish proof-of-concept for dampening inflammation in schizophrenia treatment.
Main Methods:
- A double-blind, multicentre pilot study involving 12 schizophrenia patients on stable antipsychotic regimens.
- Patients were randomized to receive either prednisolone (40 mg/day, tapered over 6 weeks) or placebo.
- The primary outcome was the change in Positive and Negative Syndrome Scale (PANSS) total score at 6 weeks.
Main Results:
- A trend towards greater reduction in psychotic symptoms was observed in the prednisolone group compared to placebo (PANSS total score difference: 15.4, p=0.101).
- A statistically significant improvement was noted in the PANSS general score for the prednisolone group (difference: 12.5, p=0.021).
- Prednisolone was found to be safe and well-tolerated during the 6-week treatment period.
Conclusions:
- Add-on prednisolone may have a beneficial effect in reducing psychotic symptoms in schizophrenia.
- Larger studies are required to confirm these preliminary findings and elucidate the mechanisms of action.
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