The Norwegian Prednisolone in Early Psychosis Study

Summary

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.

Conditions

• Schizophrenia and Related Disorders
• Immune Suppression
• Psychosis
• Cognitive Change

Interventions

DRUG

Prednisolone

Prednisolone tablets initiated at 40 mg for three days, after which it will be phased out within 6 weeks after start

OTHER

Placebo

Placebo tablets initiated at 40 mg for three days, after which it will be phased out within 6 weeks after start

Sponsors & Collaborators

• Helse Stavanger HF

  collaborator OTHER_GOV

• St. Olavs Hospital

  collaborator OTHER

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Erik Johnsen, MD, PhD · Haukeland University Hospital

• Solveig Klæbo Reitan, MD, PhD · St. Olavs Hospital

• Helle Schøyen, MD, PhD · Helse Stavanger HF

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-02

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• Norway

Study Locations