Lees 2017.
Methods |
Allocation: randomised.
Blindness: double‐blind.
Duration: 4 weeks. Settings: outpatient. Design: cross‐over. Country: UK. Study dates: unclear. |
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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. |
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Interventions |
1.Modafinil: single‐dose modafinil (200 mg) + second‐generation antipsychotic. 2. Placebo: placebo + second‐generation antipsychotic. |
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Outcomes |
Usable data:
Unable to use:
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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. |
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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. |