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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

Visit number

1

2

3

4

5

6

7

8

9

10

11

Assessment

Screening

Baseline

Week 2a

Week 4

Week 8

Week 12

Week 18a

Week 26

Week 27a

Week 36a

Week 52

Day − 21 to − 8

Day − 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 consent

x

–

–

–

–

–

–

–

–

–

–

Cohort characteristics and eligibility

 Demographics

x

–

–

–

–

–

–

x

–

–

x

 Medical and psychiatric history

x

x

–

x

x

x

–

x

–

–

x

 Inclusion/exclusion criteria for study

x

–

–

–

–

–

–

–

–

–

–

 Eligibility screen for imaging

x

–

–

–

–

–

–

–

–

–

–

 Pregnancy (urine)

x

–

–

–

–

–

–

–

–

–

–

 SCID-5-RV

–

–

–

x

–

–

–

–

–

–

–

 SCID-II PQ BPD screener/PID-5-BF

x

–

–

–

–

–

–

–

–

–

–

 WASI-II

x

–

–

–

–

–

–

–

–

–

–

 Randomisation

–

x

–

–

–

–

–

–

–

–

–

Primary outcome

 PANSS Total

–

x

–

x

x

x

–

x

–

–

x

Secondary outcomes

Symptoms

 PANSS Positive, Negative and General

–

x

–

x

x

x

–

x

–

–

x

 MADRS

–

x

–

x

x

x

–

x

–

–

x

 CGI-S

–

x

–

x

x

x

–

x

–

–

x

 CGI-I/PGI-I

–

–

–

x

x

x

–

x

–

–

x

Functioning and quality of life

 SOFAS

–

x

–

x

x

x

–

x

–

–

x

 SDS

–

x

–

x

x

x

–

x

–

–

x

 AQoL-8D

–

x

–

x

x

x

–

x

–

–

x

 SIMI-LE

–

x

–

–

–

–

–

x

–

–

–

 SIMPAQ

–

x

–

–

–

x

–

x

–

–

x

Neurocognition and imaging

 CogState

x

x

–

–

–

–

–

x

–

–

x

 SDMT

–

x

–

–

–

–

–

x

–

–

x

 Digit Span

–

x

–

–

–

–

–

x

–

–

x

 RAVLT

–

x

–

–

–

–

–

x

–

–

x

 Neuroimagingb

–

x

–

–

–

–

–

x

–

–

–

Substance use

 ASSIST

–

x

–

x

x

x

–

x

–

–

x

Research bloods

 Biomarkers and mRNAc

–

x

–

–

–

–

–

x

–

–

x

Clinical management

 Physical health assessments

–

x

–

x

x

x

–

x

–

–

x

 Concomitant medications review

x

x

x

x

x

x

x

x

x

x

x

 SAS

–

x

–

x

x

x

–

x

–

–

x

 BARS

–

x

–

x

x

x

–

x

–

–

x

 Adverse events (side-effects)

–

x

x

x

x

x

x

x

x

–

–

 Treatment adherence (MARS)

–

–

x

x

x

x

x

x

–

–

–

  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
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Trials

ISSN: 1745-6215