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The Norwegian Prednisolone in Early Psychosis Study (NorPEPS)

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ClinicalTrials.gov Identifier: NCT03340909
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
Helse Stavanger HF
St. Olavs Hospital
Information provided by (Responsible Party):
Haukeland University Hospital

Tracking Information
First Submitted Date  ICMJE November 2, 2017
First Posted Date  ICMJE November 14, 2017
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE February 2, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
Improvement of overall symptom severity [ Time Frame: 6 weeks ]
Overall symptom severity measured by the Positive and Negative Syndrome Scale. 30 items rated between 1 (symptom not present) and 7 (symptom present in the most severe degree. The sum score constitutes the overall symptom severity, and ranges between 30 - 210 Points.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03340909 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
  • Improvement of overall symptom severity after 6 and 12 months [ Time Frame: 6 and 12 months ]
    Overall symptom severity measured by the Positive and Negative Syndrome Scale. 30 items rated between 1 (symptom not present) and 7 (symptom present in the most severe degree. The sum score constitutes the overall symptom severity, and ranges between 30 - 210 Points.
  • Improvement of overall cognition [ Time Frame: 1 year ]
    Cognitive functioning as measured by the Brief Assessment of Cognition in Schizophrenia (BACS).
  • Improvement of positive symptoms [ Time Frame: 6 weeks, 6 months, 12 months ]
    The Positive subscale score as measured by the Positive and Negative Syndrome Scale. 7 items rated between 1 (symptom not present) and 7 (symptom present in the most severe degree. The range is between 7-49 points
  • Improvement of negative symptoms [ Time Frame: 6 weeks, 6 months, 12 months ]
    The Negative subscale score as measured by the Positive and Negative Syndrome Scale. 7 items rated between 1 (symptom not present) and 7 (symptom present in the most severe degree. The range is between 7-49 points
  • Improvement of general psychopathology [ Time Frame: 6 weeks, 6 months, 12 months ]
    The general psychopathology subscale as measured by the Positive and Negative Syndrome Scale. 16 items rated between 1 (symptom not present) and 7 (symptom present in the most severe degree. The range is between 16-112 points
  • Improvement og the Global Assessment of Functioning scale (GAF) [ Time Frame: 6 weeks, 6 months, 12 months ]
    GAF is scored between 1 (lowest possible functioning) and 100 (best possible functioning).
  • Change of depressive symptoms [ Time Frame: 6 weeks, 6 months, 12 months ]
    Severity of depression is assessed using the Calgary Depression Scale for Schizophrenia, which has 9 items scored as 0 (symptom not present), 1 (mild degree), 2 (moderate degree), or 3 (severe degree of symptom). This makes a possible sub score range between 0 and 27).
  • Number of participants with treatment-related adverse events as assessed by the UKU Side Effects Rating Scale [ Time Frame: 12 months ]
    Occurrence and severity of severe adverse events and suspected unexpected severe adverse reaction as measured by the UKU Side Effects Rating Scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Norwegian Prednisolone in Early Psychosis Study
Official Title  ICMJE The Norwegian Prednisolone in Early Psychosis Study - NorPEPS. The Role of Immune-modulating Strategies in the Treatment of Psychosis
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Placebo-controlled randomized 1:1 comparison.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia and Related Disorders
  • Immune Suppression
  • Psychosis
  • Cognitive Change
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Prednisolone
    Prednisolone tablets 5 mg
    Intervention: Drug: Prednisolone
  • Placebo Comparator: Placebo
    Placebo tablets with identical appearance to the experimental drug.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or schizoaffective disorder) or 298.9 (psychosis NOS)
  2. Onset of psychosis no longer than 5 years ago
  3. Minimum total PANSS score of 60 Age 18 -70 years.
  4. Patients are treated with antipsychotic medication
  5. Plasma level of CRP is > 3.9 mg/L at screening (through 'high sensitivity' measurement)
  6. Written informed consent is obtained
  7. Female patients of childbearing potential need to utilize a proper method of contraception (the pill, vaginal ring, hormonal patch, intrauterine device, cervical cap, condom, contraceptive injection, diaphragm) in case of sexual intercourse during the study.

Exclusion Criteria:

  1. Presence of any of the contra-indications of prednisolone as reported in the SPC. These include hypersensitivity to any ingredients in the formulation, systemic infections unless specific anti-infective therapy is employed, patients with ocular herpes simplex due to the possibility of perforation, recent vaccination with live or weakened virus or bacteria. Also the following special warnings in the SPC will represent exclusion criteria: Existing or previous history of severe affective disorders in themselves or in their first degree relatives, including depressive or bipolar disorders or previous steroid psychosis, glaucoma or family history of glaucoma, hypertension or heart failure, liver impairment and/ or failure, epilepsy, osteoporosis, peptic ulceration, previous steroid myopathy, renal insufficiency, history of tuberculosis or x-ray changes characteristic of tuberculosis, recent myocardial infarction, chickenpox, measles.
  2. Presence of diabetes mellitus or random (non-fasting) glucose levels exceeding 11 mmol/L at screening, or family history of diabetes.
  3. Body Mass Index (BMI) of >27.5
  4. Current or chronic use of systemic glucocorticosteroids (temporary use is permitted, if stopped before start of treatment trial)
  5. Chronic use of non-steroidal anti-inflammatory drugs, defined as daily use during more than 2 months. Intermittent use is permitted, if stopped at least 1 month before start of treatment trial.
  6. Pregnancy or breast-feeding. A urine pregnancy test will be performed at screening and then after 6 weeks of treatment and the event of treatment discontinuation.
  7. Concurrent use of certain types of medication:

1. liver enzyme inducing medication such as carbamazepine, riphampicine, primidone, barbiturates and phenytoine 2. HAART (both HIV protease inhibitors and (non)-nucleoside reverse transcriptase inhibitors), especially efavirenz, ritonavir and lopinavir.

3. telaprevir and boceprevir in treatment of Hepatitis C

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Erik Johnsen, MD, PhD +47 55958400 erik.johnsen@helse-bergen.no
Contact: Rune A Kroken, MD, PhD +47 55958400 rune.andreas.kroken@helse-bergen.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03340909
Other Study ID Numbers  ICMJE 2017/620/REK vest
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE
  • Helse Stavanger HF
  • St. Olavs Hospital
Investigators  ICMJE
Principal Investigator: Erik Johnsen, MD, PhD Haukeland University Hospital
Principal Investigator: Arne Vaaler, MD, PhD St. Olavs Hospital
Principal Investigator: Helle Schøyen, MD, PhD Helse Stavanger HF
PRS Account Haukeland University Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP