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Table 2 Schedule of trial assessments and procedures

From: Study protocol for Ketamine as an adjunctive therapy for major depression (2): a randomised controlled trial (KARMA-Dep [2])

 

Inpatient

Follow-up

 

Treatment

 

Assessment

Screening Visit 0

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

Visit 8/Final Infusion Visit

Visit 9

Visit 10

Visit 11

  

Week 1

Week 2

Week 3

Week 4

6 weeks± 1 week

12 weeks± 2 weeks

24 weeks ± 3 weeks

Informed Consent

X

           

Inclusion/Exclusion criteria

X

X

X

X

X

X

X

X

X

   

Past and current medical conditions

X

           

Demographics

X

           

MINI, ATRQ

X

           

Physical exam

X

           

Height, weight, BMI

X

X

 

X

 

X

 

X

    

ECG

 

X

X

X

X

X

X

X

X

   

Clinical laboratory assessments

X

       

X

   

Blood pregnancy test

X

           

Vital signs

 

X

X

X

X

X

X

X

X

   

Randomisation

X

           

Treatment review

 

X

X

X

X

X

X

X

X

X

X

X

Drug administration

 

X

X

X

X

X

X

X

X

   

MADRS

X

X

X

X

X

X

X

X

X

X

X

X

QIDS-SR16

X

X

X

X

X

X

X

X

X

X

X

X

MoCA

X

X

      

X

 

X

X

OAA/S-R

 

X

X

X

X

X

X

X

X

   

CADSS

 

X

X

X

X

X

X

X

X

   

BPRS

 

X

X

X

X

X

X

X

X

   

YMRS

 

X

X

X

X

X

X

X

X

   

PRISE

X

X

X

X

X

X

X

X

X

X

X

X

AE review

 

X

X

X

X

X

X

X

X

X

X

X

SAE review

 

X

X

X

X

X

X

X

X

X

X

X

PWC-20

X

   

X

   

X

X

X

 

Concomitant medication

X

X

X

X

X

X

X

X

X

   

Healthcare costs: CSRI, medications costs

X

        

X

X

X

EQ-5D-5L

X

        

X

X

X

Drug accountability

 

X

X

X

X

X

X

X

X

   

Assessment of patient and rater blinding

 

X

      

X

  

X

Fasting

 

X

X

X

X

X

X

X

X

   
  1. MINI Mini-International Neuropsychiatric Interview, ATRQ Antidepressant Treatment Response Questionnaire, BMI Body mass index, ECG Electrocardiogram, MADRS Montgomery-Åsberg Rating Scale for Depression, QIDS-SR16 Quick Inventory of Depressive Symptoms, MoCA Montreal Cognitive Assessment, OAA/S-R Observer’s Assessment of Alertness/Sedation Scale - Responsiveness Subscale, CADSS Clinician-administered Dissociative States Scale, BPRS Brief Psychiatric Rating Scale, YMRS Young Mania Rating Scale, PRISE Patient-Rated Inventory of Side Effects, AE Adverse event, SAE Serious adverse event, PWC-20 20-item Physician Withdrawal Checklist, CSRI Client Service Receipt Inventory, EQ-5D-5L EuroQol-5 dimensions-5 level scale for health status
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BMC Psychiatry

ISSN: 1471-244X

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