Prednisolone Addition for Patients With Recent-onset Psychotic Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02949232|
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Psychotic Disorder NOS||Drug: Prednisolone Drug: Placebo Oral Tablet||Phase 4|
In the current study, the investigators aim to investigate the effect of additional treatment with prednisolone on symptomatic improvement, global functioning, cognition and on immunological parameters in patients with early-stage psychotic disorder, applying a randomized double-blind placebo-controlled add-on design. A placebo-controlled design was chosen in order to differentiate between clinical effects of prednisolone and effects associated with experimental treatment, such as induced expectations of participants. Prednisolone or placebo is provided next to existent antipsychotic medication as the investigators do not intend to replace existing treatment, this study being a Proof of Concept trial. It would carry considerable risks for patients to taper down existent antipsychotic medication and randomize patients to either placebo or a type of therapy for which the efficacy still has to be proven, even for a short period of time.
90 patients with schizophrenia, schizoaffective or schizophreniform disorder, or psychotic disorder NOS (not otherwise specified) will be included, with an age of 18-70 years and a time interval between the onset of psychosis and study entry not exceeding seven years. All 90 in- and outpatients will be randomized 1:1 to either prednisolone or placebo daily for 6 weeks. Prednisolone will be initiated at 40mg/day for 3 days and the 4 remaining days of the first week 30mg/dag will be used. During the treatment period, patients will be seen at weekly intervals to assess symptom severity, depressive mood and suicidal ideation, global functioning and side effects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prednisolone Addition for Patients With Recent-onset Psychotic Disorder: the Role of Immune-modulating Strategies in the Treatment of Psychosis|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Prednisolone will be initiated at 40 mg for three days, after which it will be phased out within 6 weeks after start, following treatment guidelines for Inflammatory Bowel Diseases (2008).
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).
Placebo Comparator: Placebo Oral Tablet
Placebo will be initiated at 40 mg for three days, after which it will be phased out within 6 weeks after start, following the treatment schedule of the experimental arm
Drug: Placebo Oral Tablet
Dosing following the tapering scheme of the treatment of the treatment arm
- Change in symptom severity [ Time Frame: 6 weeks ]Change in symptom severity is expressed as a change in total score on the Positive and Negative Symptom Scale (PANSS) from baseline to end of the 6-week treatment.
- Improvement in cognitive functioning [ Time Frame: 6 months ]Cognitive functioning is measured through the Brief Assessment of Cognition in Schizophrenia (BACS).
- Change in GAF scores [ Time Frame: 1 year ]Global Assessment of Functioning
- Measurement of various immunological biomarkers [ Time Frame: 6 months ]
- Improvement of PANSS scores in follow-up [ Time Frame: 1 year ]
- Score on the Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: 6 weeks ]
- Incidences of key SAEs and SUSARs [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949232
|Contact: Inge Winter, Dr.||+31 88 755 firstname.lastname@example.org|
|Antwerp, Belgium, 2060|
|Contact: Jurjen Luykx, Dr. +32 32177881 email@example.com|
|University Aarhus||Not yet recruiting|
|Risskov, Denmark, 8240|
|Contact: Micheal Benros, Dr. +45 26255239 firstname.lastname@example.org|
|Sliedrecht, Netherlands, 3361XV|
|Contact: Arthur van Gool, Dr. +31 88 40 50 600 email@example.com|
|Utrecht, Netherlands, 3508 GA|
|Contact: Iris Sommer, Prof. Dr. +31 88 755 6370 I.firstname.lastname@example.org|
|Principal Investigator:||Iris Sommer, Prof. Dr.||UMC Utrecht|