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Table 1 Collection of data

From: Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial protocol

 

Baseline

2 months*

4 months*

6 months*

Benzodiazepines (dose)

X

X

X

X

Co medication

X

X

X

X

Neurocognition (BACS)

X

X

X

X

Psychophysiology

X

X

X

X

Sleep assessment (PSG)

X

  

X

Psychopathology (PANSS)

X

  

X

Quality of life (WHO-5 and SWN-S)

X

X

X

X

Withdrawal symptoms (BWSQ-2)

X

X

X

X

Subjective sleep quality (PSQI)

X

  

X

Social functioning (PSP)

X

X

X

X

Laboratory tests

X

  

X

Lifestyle factors

X

  

X

Physical examination

X

  

X

Sociodemographic characteristics

X

   

Plasma benzodiazepines

   

X

Adverse events

 

X

X

X

  1. *After initiating trial medication and benzodiazepine withdrawal.
  2. BACS: Brief Assessment of Cognition in Schizophrenia
  3. PSG: Polysomnography
  4. PANSS: Positive and Negative Syndrome Scale
  5. WHO-5: WHO-5 Well-Being Scale
  6. SWN-S: Subjective Well-being under Neuroleptic Treatment scale (short form)
  7. BWSQ-2: Benzodiazepine Withdrawal Symptom Questionnaire
  8. PSQI: Pittsburgh Sleep Quality Index
  9. PSP: Personal and Social Performance Scale