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Table 1 Schedule of assessments

From: A randomised double-blind placebo-controlled 12- week feasibility trial of methotrexate added to treatment as usual in early schizophrenia: study protocol for a randomised controlled trial

Assessment

Who

When

Patient

Research assistants

RMO team

Screening

Randomisation

Week 2

Week 4

Week 8

Week 12

Case note review

  

x

     

x

SCID

 

x

 

x

     

Drug treatment history

 

x

 

x

x

x

x

x

x

Medical history

  

x

x

     

Physical exam

 

x

 

x

    

x

Body weight and BMI

 

x

  

x

   

x

BP and HR

 

x

 

x

x

x

x

x

x

Lab screena

  

x

x

 

x

x

x

x

Pregnancy screen (urine)

 

x

  

x

  

x

x

Inclusion criteria

 

x

 

x

     

Exclusion criteria

 

x

 

x

     

Withdrawal criteria

 

x

  

x

x

x

x

 

Consent

x

x

 

x

x

    

PANNS

 

x

  

x

x

x

x

x

CGI

 

x

  

x

x

x

x

x

GAF

 

x

  

x

   

x

QOL

 

x

  

x

   

x

Social function scale

 

x

  

x

   

x

Cognitive assessments

 

x

  

x

   

x

Antipsychotic side-effects

 

x

  

x

x

x

x

x

Side-effects

         

Spontaneously reported adverse effects and

         

methotrexate toxicity check list

x

x

  

x

x

x

x

x

Compliance monitoring

 

x

   

x

x

x

x

  1. aLab screen includes FBC, renal function and liver functions tests. Patients will continue to have these tests at 2-weekly intervals if there are abnormalities on the 6-week blood tests that do not warrant withdrawal from the study. These blood tests are also repeated 4 weeks after finishing the study. Additional blood tests are conducted at baseline and 12 weeks.
  2. Abbreviations: BMI body mass index, BP blood pressure, CGI Clinical Global Impression, FBC full blood count, GAF Global Assessment of Functioning, HR heart rate, PANNS Positive and Negative Syndrome Scale, QOL quality of life, RMO resident medical officer, SCID Structured Clinical Interview for DSM-IV.