Clinical Trials Register

Summary
EudraCT Number:	2014-000520-14
Sponsor's Protocol Code Number:	NL46653
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-04-19
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2014-000520-14

A.3

Full title of the trial

Prednisolone addition for patients with recent onset psychotic disorder: the role of immune-modulating strategies in the treatment of psychosis.

Prednisolone additie voor patiënten met een recent ontstane psychotische stoornis: De rol van immuun-modulerende strategieën in de behandeling van psychose.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Prednisolone use next to standard treatment for patients with recent onset psychotic disorder: what is the effect of medication that affects the immune system?

Prednison gebruik naast de standaard behandeling voor patiënten met recent ontstane psychotische stoornis: Wat is het effect van medicatie die het afweersysteem beïnvloedt?

A.3.2

Name or abbreviated title of the trial where available

Prednisolone addition for patients with recent onset psychotic disorder.

Prednisolon additie voor patiënten met een recent ontstane psychotische stoornis.

A.4.1

Sponsor's protocol code number

NL46653

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University Medical Center Utrecht
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Stanley Medical Research Institute
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Medical Center Utrecht
B.5.2	Functional name of contact point	Division Neuroscience, Prednisolon
B.5.3	Address:
B.5.3.1	Street Address	Heidelberglaan 100
B.5.3.2	Town/ city	Utrecht
B.5.3.3	Post code	2584 CX
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	0031887571032
B.5.6	E-mail	prednisolonstudie@umcutrecht.nl

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Prednisolone Mylan
D.2.1.1.2	Name of the Marketing Authorisation holder	Mylan
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Prednisolone Mylan
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Prednisolone
D.3.9.1	CAS number	50-24-8
D.3.9.3	Other descriptive name	PREDNISOLONE
D.3.9.4	EV Substance Code	SUB10018MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Schizophrenia, schizophreniform disorder, schizzoaffective disorder, psychotic NOS.

E.1.1.1

Medical condition in easily understood language

Schizophrenia, psychosis-related disorder.

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Different lines of evidence now suggest that low grade inflammation in central lines of the central nervous system is involved in the pathogenesis of schizophrenia. Such inflamation could cause increased gray matter loss and consequently contribute to more severe negative and cognitive symptoms. We propose to investigate the effect of administering prednisolone ( a broad-acting, potent immune suppressive agent) versus placebo, psychotic symptoms, in addition to standard antipsychotical medication in patients with early stage schizophrenia or related disorders. This may prevent neural damage caused by low grade inflammatory processes in the brain. It is expected that symptom severity will be improved with prednisolone use.

E.2.2

Secondary objectives of the trial

Secondary objectives concern the comparison of the 2 groups with regards to change in:
-Positive and Negative Symptom Scale (PANSS) subscales.
-Cognitive performance (Brief Assessment of Cognitive Functioning; BACS).
-General functioning (Global Assessment of Functioning)
-Depressive Symproms (Calgary Depression Scale for Schizophrenia)
-Safety data will be evaluated by comparing indices of kay SAEs and SUSARs

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. A DSM-IV-TR diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or
schizoaffective disorder) or 298.9 (psychosis NOS)
2. Onset of psychosis no longer than 7 years ago
3. Minimum total PANSS score of 60.
4. Age 18 -70 years.
5. Patients are treated with antipsychotic medication
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.

E.4

Principal exclusion criteria

1. Presence of any of the contra-indications of prednisolone as reported in the SPC.
2. Presence of diabetes mellitus or random (non-fasting) glucose levels exceeding 11 mmol/L at screening, severe heart failure, severe osteoporosis or systemic fungal infections.
3. Body Mass Index (BMI) of >30.0
4. Current or chronic use of systemic glucocorticosteroids (temporary use is permitted, if stopped 1 month 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.
7. Concurrent use of certain types of medication:
a. liver enzyme inducing medication such as carbamazepine, riphampicine, primidone, barbiturates and phenytoine
b. HAART medication (both HIV protease inhibitors and (non)-nucleoside reverse transcriptase inhibitors), especially efavirenz, ritonavir and lopinavir.
c. telaprevir and boceprevir in treatment of Hepatitis C

E.5 End points

E.5.1

Primary end point(s)

Change in total score on the PANSS form baseline to end point (6 weeks assessment).

E.5.1.1

Timepoint(s) of evaluation of this end point

6 weeks after treatment.

E.5.2

Secondary end point(s)

Secondary objectives concern the comparison of the 2 groups with regards to change in:
-Change in total score on the PANSS form in follow-up
-Positive and Negative Symptom Scale (PANSS) subscales.
-Cognitive performance (Brief Assessment of Cognitive Functioning; BACS).
-General functioning (Global Assessment of Functioning)
-Depressive Symproms (Calgary Depression Scale for Schizophrenia)
-Safety data will be evaluated by comparing indices of kay SAEs and SUSARs

E.5.2.1

Timepoint(s) of evaluation of this end point

6, 16, 26 & 52 weeks after start treatment

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.6.13.1

Other scope of the trial description

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

After the 6 weeks prednisolone / placebo treatment, there is no option to continue to use prednisolone within the study. The unblinding will be performed after the data base closure; in case we find at that moment that prednisolone has been very effective for individual patients, we can discuss the situation with the treating physician at that time. Most likely, additional diagnostical procedures will have to take place such as liquor function.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-03-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-03-11

P. End of Trial
P.	End of Trial Status	Ongoing

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