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. 2019 Dec 12;2019(12):CD008661. doi: 10.1002/14651858.CD008661.pub2

Michalopoulou 2015.

Methods Allocation: randomised.
 Blindness: double‐blind.
 Duration: 2 weeks.
Settings: outpatients.
 Design: parallel.
Country: UK
Study dates: December 2010 to September 2012.
Participants Diagnosis: schizophrenia (DSM‐IV).
N = 49.
Age: ˜36.3 years.
Sex: 35 M, F 13.
Length of illness: ˜12 years.
History: chronic, clinically stable.
Interventions 1. Modafinil: modafinil 200 mg + antipsychotic treatment + cognitive training (10 days).
2. Placebo: placebo + antipsychotic treatment + cognitive training (10 days).
Outcomes Usable data:
  1. Cognitive function: MCCB (composite score, speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition).

  2. Leaving the study early.

  3. Specific adverse events: nausea, insomnia, dizziness, headache, dry mouth, nervousness, anxiety, rhinitis, back pain, diarrhoea, dyspepsia, pharyngitis, anorexia, chest pain, hypertension, tachycardia, palpitations, constipation, flu syndrome.


Unable to use:
  1. Mental state: PANSS total, positive, negative, general (skewed data).

Notes Trial registry: ISRCTN60687844.
Funding: Innovative Medicines Initiative Joint Undertaking.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Stratified randomisation was performed for two preselected factors (gender and smoking status) with known effects on cognition."
Allocation concealment (selection bias) Low risk "To ensure concealment of the randomisation assignment, medication was provided in coded bottles containing identical capsules of active drug or placebo."
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "To ensure concealment of the randomisation assignment, medication was provided in coded bottles containing identical capsules of active drug or placebo."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "All raters were blind to treatment assignment."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Intention‐to‐treat analysis using mixed‐effect models.
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported.
Other bias Low risk We found no other bias.