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Table 1 Schedule of assessments

From: Efficacy and safety of scopolamine compared to placebo in individuals with bipolar disorder who are experiencing a depressive episode (SCOPE-BD): study protocol for a randomised double-blind placebo-controlled trial

Procedures

Visit 1

Screening

Visit 2

PLACEBO

Visit 3

Randomisation

Day 0

Scopolamine or placebo

Visit 4

Day 4 (± 2 days)

Scopolamine or placebo

Visit 5

Day 8 (± 2 days)

Scopolamine or placebo

Visit 6

Day 15 (± 5 days)

Follow-Up

Visit 7

Day 29 (± 7 days)

Follow-Up

IV infusion

IV infusion

IV infusion

IV infusion

Pre

During

Post

Pre

During

Post

Pre

During

Post

Pre

During

Post

Signed informed consent

X

              

Inclusion/exclusion

X

X

  

X

          

Randomisation

    

X

          

IWRS

    

X

  

X

  

X

    

Demography

X

              

MEHI

X

              

Medical/surgical history/history BPD

X

              

Current medication

X

X

  

X

  

X

  

X

  

X

X

Vital signs—HR, BP, and RR

X

X

 

X

X

 

X

X

 

X

X

 

X

  

SCID-RV

X

              

HDRS

X

X

  

X

  

X

  

X

  

X

X

YMRS

X

X

  

X

  

X

  

X

  

X

X

AUDIT

X

              

Pregnancy discussion

X

X

  

X

  

X

  

X

    

Contraception advice

X

X

  

X

  

X

  

X

    

Serum pregnancy testΔ

 

X

             

Pregnancy urine dipstickΔ

 

X

  

X

  

X

  

X

    

U&Es, LFTs, TFTs°

X

X

             

Fagerstrom

 

X

             

CGI-S

 

X

  

X

  

X

  

X

  

X

X

CGI-I

    

X

  

X

  

X

  

X

X

VAS

 

X

 

X

X

 

X

X

 

X

X

 

X

  

MADRS

 

X

  

X

  

X

  

X

  

X

X

GAF

    

X

     

X

  

X

X

ECG

 

X

             

Height (cm) and weight (kg)

 

X

             

IV cannulation

 

X

  

X

  

X

  

X

    

Infusion administration

  

X

  

X

  

X

  

X

   

Adverse events

 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Cannulation site check

 

X

 

X

X

 

X

X

 

X

X

 

X

  

POMS (optional)

 

X

 

X

X

 

X

X

 

X

X

 

X

X

X

CANTAB b (optional)

   

X

  

X

      

X

 

WAIS a (optional)

   

Xa

  

Xa

  

Xa

  

Xa

Xa

Xa

NEO-PI-FFI a (optional)

   

Xa

  

Xa

  

Xa

  

Xa

Xa

Xa

PRISE (optional)

   

X

  

X

  

X

  

X

  

Subjective assessment

              

X

  1. aCan be undertaken at any of the marked visit
  2. bThese include the Emotion Recognition Task (ERT), Paired Associates Learning (PAL), One Touch Stockings of Cambridge (OTC) and Rapid Visual Information Processing (RVP) (assesses attention) tests
  3. ΔPregnancy test (serum pregnancy test and pregnancy urine dipstick), when required, for female participants only. Serum result confirmed prior to visit 3
  4. °Blood tests for U&Es (urine and electrolytes), LFTs (Liver Function Tests) and TFTs (Thyroid Function Tests) should be confirmed within acceptable ranges in the previous 4 months of the screening (visit 1). Can be performed if required at visit 1 or 2 (results must be confirmed as acceptable prior to infusion)
  5. AUDIT, Alcohol Use Disorder Identification Test; BP, blood pressure; CANTAB, Cambridge Neuropsychological Test Automated Battery; CGI-I, Clinical Global Impression—Improvement; CGI-S, Clinical Global Impression—Severity; ECG, electrocardiograph; Fagerstrom, Test for Nicotine Dependence; GAF, Global Assessment of Functioning; HDRS, Hamilton Depression Rating Scale; HR, heart rate; IV, intravenous; IWRS, Interactive Web Response System; MADRS, Montgomery and Asberg Depression Rating Scale; MEHI, Modified Edinburgh Handedness Inventory; NEO PI-FFI, NEO Personality Inventory-Five Factor Inventory; POMS, Profile of Mood States; PRISE, Patient Rated Inventory of Side Effects; RR, respiratory rate; SCID-RV, Structured Clinical Interview for DSM; VAS, Visual Analogue Scale; YMRS, Young Mania Rating Scale; WAIS, Wechsler Adult Intelligence Scale