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Prednisolone Addition for Patients With Recent-onset Psychotic Disorder

NCT02949232 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-06-24

No results posted yet for this study

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.

Conditions

  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder
  • Psychotic Disorder NOS

Interventions

DRUG

Prednisolone

prednisolone will be will be initiated during the first week at 40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks; in the second week, patients will use 25 mg/day, in the third week 20 mg/day is used etc. In the last week the patients will only take prednisolone on day 1-3 and day 5 and 7; a tapering scheme in line with the treatment guidelines for Inflammatory Bowel Diseases (2008).

DRUG

Placebo Oral Tablet

Dosing following the tapering scheme of the treatment of the treatment arm

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Iris Sommer, Prof. Dr. · UMC Utrecht

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
2014-07-31
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Belgium
  • Denmark
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02949232 on ClinicalTrials.gov