Prednisolone Addition for Patients With Recent-onset Psychotic Disorder
Summary
Treatment with prednisolone can be used as a proof of concept to investigate the possibility of immune modulation as a treatment for schizophrenia. It is expected that daily treatment with prednisolone in addition to antipsychotic treatment reduces psychotic symptoms and improves cognition, as compared to placebo. The investigators propose to investigate the effects of administering the corticosteroid prednisolone versus placebo in addition to standard antipsychotic medication in patients with early stage schizophrenia or related disorders, hypothesizing that a decrease in the overall low-grade cerebral inflammation due to prednisolon treatment will be expressed as a decrease in overall symptom severity., Secondly, addition of prednisolone is hypothesised to slow down cognitive deterioration in recent-onset psychosis patients. Finally, the investigators aim to determine whether indirect immunological parameters of the hypothesised low grade inflammation status in schizophrenia are shifted due to the addition of prednisolone.
Timeline
- Start
- 2014-07
- Primary completion
- 2019-05
- Completion
- 2019-05
Outcome
Missed primary endpoint
Stopped (Enrollment): “Difficulties with recruitment”
paper The degree of improvement was not significantly different between treatment arms (p=0.96). PMID 33711681 ↗
paper Adjunctive treatment with prednisolone did not improve symptom severity compared to placebo in patients with schizophrenia. PMID 33711681 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prednisolone | Other / unclassified | 5 mg | — |