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Table 1 Patient visits and examinations specified per visit

From: Prednisolone versus placebo addition in the treatment of patients with recent-onset psychotic disorder: a trial design

 

Visit 1

− 12 to 0 weeks (screening)

Visit 2

week 0 (baseline)

Visit 3

week 1

Visit 4

week 2

Visit 5

week 3

Visit 6

week 4

Visit 7

week 5

Visit 8

week 6 (end of treatment)

Visit 9

week 16

Visit 10

week 26

Visit 11

week 52

Early termination visit*

Informed consent, MINI, demographics

X

           

Eligibility criteria

X

           

Medical history, current medical conditions

X

           

Physical examination, BMI, ECG

X

           

Pregnancy testing

X

X

     

X

   

X

MRI**

X

         

X

 

Use of concomitant medication

X

X

X

X

X

X

X

X

X

X

X

X

Dispense study medication

 

X

X

X

X

X

X

     

Randomization

 

X

          

Drugs/alcohol use

X

   

X

  

X

   

X

Side effects, compliance

  

X

X

X

X

X

X

   

X

PANSS, GAF

X

X

 

X

 

X

 

X

X

X

X

X

Suicidal behavior, CDS, hospitalization

 

X

X

X

X

X

X

X

X

  

X

BACS

 

X

     

X

 

X

 

X

Blood/ urine samples

X

X

***

***

X

***

***

X

 

X

 

X

  1. MINI Mini International Neuropsychiatric Interview, BMI body mass index, ECG electrocardiogram, MRI magnetic resonance imaging, PANSS Positive And Negative Syndrome Scale, GAF General Assessment of Functioning, CDS Calgary Depression Scale, BACS Brief Assessment of Cognition in Schizophrenia
  2. *Will be performed if a patient prematurely discontinues the study
  3. **Optional part of the study in Norway
  4. ***Fasting glucose only, in Norway only