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Table 1 Schedule of assessments

From: ENACT: a protocol for a randomised placebo-controlled trial investigating the efficacy and mechanisms of action of adjunctive N-acetylcysteine for first-episode psychosis

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AssessmentScreeningBaselineWeek 2aWeek 4Week 8Week 12Week 18aWeek 26Week 27aWeek 36aWeek 52
Day − 21 to − 8Day − 7 to 1± 3 days± 7 days± 7 days± 7 days± 7 days± 14 days± 3 days± 28 days± 28 days
       (end of treatment)  (end of study)
Informed consentx
Cohort characteristics and eligibility
 Demographicsxxx
 Medical and psychiatric historyxxxxxxx
 Inclusion/exclusion criteria for studyx
 Eligibility screen for imagingx
 Pregnancy (urine)x
 SCID-5-RVx
 SCID-II PQ BPD screener/PID-5-BFx
 WASI-IIx
 Randomisationx
Primary outcome
 PANSS Totalxxxxxx
Secondary outcomes
Symptoms
 PANSS Positive, Negative and Generalxxxxxx
 MADRSxxxxxx
 CGI-Sxxxxxx
 CGI-I/PGI-Ixxxxx
Functioning and quality of life
 SOFASxxxxxx
 SDSxxxxxx
 AQoL-8Dxxxxxx
 SIMI-LExx
 SIMPAQxxxx
Neurocognition and imaging
 CogStatexxxx
 SDMTxxx
 Digit Spanxxx
 RAVLTxxx
 Neuroimagingbxx
Substance use
 ASSISTxxxxxx
Research bloods
 Biomarkers and mRNAcxxx
Clinical management
 Physical health assessmentsxxxxxx
 Concomitant medications reviewxxxxxxxxxxx
 SASxxxxxx
 BARSxxxxxx
 Adverse events (side-effects)xxxxxxxx
 Treatment adherence (MARS)xxxxxx
  1. aAssessment completed by telephone
  2. bImaging protocol includes functional magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS)
  3. cResearch bloods including blood-derived measures of inflammatory, oxidative and nitrosative stress, and gene expression (if consent provided)
  4. Note: AQoL-8D Assessment of Quality of Life – 8 Dimensions, ASSIST Alcohol, Smoking and Substance Use Involvement Screening Test, BARS Barnes Akathisia Rating Scale, CGI-I Clinical Global Impressions – Improvement, CGI-S Clinical Global Impressions – Severity of Illness, MADRS Montgomery-Asberg Depression Rating Scale, MARS Medication Adherence Scale, mRNA messenger ribonucleic acid, PGI-I Patient Global Impressions – Improvement, PID-5 Personality Inventory for DSM-5, PANSS Positive and Negative Symptom Scale, RAVLT Rey Auditory Verbal Learning Test, SDS, Sheehan Disability Scale, SIMI-LE Social Inclusion for People with Mental Illness – Long Edition, SIMPAQ Simple Physical Activity Questionnaire, SAS Simpson-Angus Scale, SOFAS Social and Occupational Functioning Scale, SCID-5 Structured Clinical Interview for DSM-5, SCID-II PQ BPD Structured Clinical Interview for DSM-IV Axis II Disorders Personality Questionnaire, SDMT Symbol Digit Modality Test, WASI-II Wechsler Abbreviated Scale of Intelligence – Second Edition