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Table 1 Schedule of trial assessments

From: A protocol for a randomised controlled, double-blind feasibility trial investigating fluoxetine treatment in improving memory and learning impairments in patients with mesial temporal lobe epilepsy: Fluoxetine, Learning and Memory in Epilepsy (FLAME trial)

Procedure

Schedule

Eligibility assessment

Baseline assessments

Study drug

Follow-up assessment 1

Follow up assessment 2

Visit number

1

2

3

4

 

5

6

7

8

9

10

11

Time-point of visit

T-1 to 4 weeks

T0

T1

T-21

T22-T104

T83

T84

T[97-104]

T104

T164

T165

T185

Written informed consent

X

      

HADS

X

      

WASI

X

      

Blood tests (liver function, electrolytes)

X

      

ECG (where indicated)

X

      

MRI Safety Questionnaire

X

   

X

  

Issue of seizure diary

X

      

Structural MRI

X

   

X

  

Review of seizure frequency

 

X

X

X

 

X

X

 

X

X

X

X

QOLIE-31

 

X

   

X

   

X

  

Written Cognitive Assessments

 

X

          

Virtual Water Maze Task

 

X

X

X

 

X

X

 

X

X

X

X

Pattern separation task

 

X

   

X

   

X

  

Word Lists

 

X

X

X

 

X

X

 

X

X

X

X

Medical Outcomes Sleep Survey

 

X

   

X

   

X

  

Issue of SenseCam

 

X

   

X

   

X

  

Testing of SenseCam

 

X

X

X

 

X

X

 

X

X

X

X