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Table 1 Overview of all measurements, instruments and time points

From: Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol)

Variables

Sources

Study period

Enrolment

Intervention

Follow-up

Screening

Baseline (week 0)

Visit 2 (week 2)

Visit 3 (week 10)

Visit 4 (week 20)

Visit 5 (week 24)

MADRS

Rater

X

 

X

X

X

X

MES, WHO-5, GAF-S, GAF-F, CGI-S YMRS

Rater/self-reported

 

X

X

X

X

X

M.I.N.I.-Interview

Rater

X

     

Demographic (age, gender, height, inclusion site, etc.)

Self-reported

 

X

    

Weight and BMI

Rater

 

X

X

X

X

X

Personal and demographic details (income source, education, relationship etc.)

Self-reported

 

X

    

Family mental history

Self-reported

 

X

    

Lifestyle information (smoking status, alcohol consumption and substance abuse)

Self-reported

 

X

X

X

X

X

Disorder information (no. of: episodes of depression, hypomania/mania, neutral mood, ECT, hospital admissions, suicidal thoughts, suicide attempts, etc.)

Self-reported/hospital record

 

X

    

Medical conditions (Doctor diagnosed)

Self-reported

 

X

    

Pharmacological treatment

Hospital record

 

X

X

X

X

X

Psychological treatment

Self-reported

 

X

X

X

X

X

Adverse events/reactions

Self-reported

 

X

X

X

X

X

Biography

Self-reported

  

X

   

Urine samples

Laboratory

 

X

X

X

X

X

Blood samples

Laboratory

 

X

  

X

X

DNA

Laboratory

 

X

  

X

X

  1. Screening pre-intervention, Baseline pre-intervention (week 0), Visit 2 week 2, Visit 3 week 10, Visit 4 post-intervention (week 20), Visit 5 follow-up (week 24), Rater coordinating investigator/project nurse, MADRS Montgomery-Ă…sberg Depression Rating Scale score, MES Bech-Rafaelsen Melancholia Scale, WHO-5 World Health Organization well-being index, GAF-S The Global Assessment of Symptoms scale, GAF-F The Global Assessment of Functioning scale, YMRS Young Mania Rating Scale (YMRS), CGI-S The Clinical Global Impression-Severity scale (CGI-I), M.I.N.I-interview Mini International Neuropsychiatric Interview, ECT electroconvulsive therapy