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

Lees 2017.

Methods Allocation: randomised.
 Blindness: double‐blind.
 Duration: 4 weeks.
Settings: outpatient.
 Design: cross‐over.
Country: UK.
Study dates: unclear.
Participants Diagnosis: schizophrenia (DSM‐IV) and healthy volunteers
N = 46 (participants with schizophrenia)
Age: ˜25 years
Sex: 30 M, 10 F (participants that completed the study).
History: clinically stable in a non‐acute phase.
Interventions 1.Modafinil: single‐dose modafinil (200 mg) + second‐generation antipsychotic.
2. Placebo: placebo + second‐generation antipsychotic.
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. Cognitive function: CANTAB.


Unable to use:
  1. Leaving the study early (unclear to which group participants belonged).

Notes Data not presented for phase A of the study, but this information was provided by the author.
Trial registry: ISRCTN66900787.
Funding: EU Innovative Medicines Initiative to the NEWMEDS programme.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Carried out via an online system at the King's Clinical Trials Unit, was by minimisation."
Allocation concealment (selection bias) Low risk "Carried out via an online system at the King's Clinical Trials Unit, was by minimisation."
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "Capsules were supplied in coded bottles containing identical capsules of modafinil and placebo"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "Capsules were supplied in coded bottles containing identical capsules of modafinil and placebo"
Incomplete outcome data (attrition bias) 
 All outcomes High risk "Six schizophrenia participants withdrew following randomisation" Comment: Unable to obtain the information for this.
Selective reporting (reporting bias) Low risk Outcomes of interest in the review were reported in a manner not imputable in a meta‐analysis, however data provided by author.
Other bias Low risk We found no other bias.