Michalopoulou 2015.
Methods |
Allocation: randomised.
Blindness: double‐blind.
Duration: 2 weeks. Settings: outpatients. Design: parallel. Country: UK Study dates: December 2010 to September 2012. |
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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. |
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Interventions |
1. Modafinil: modafinil 200 mg + antipsychotic treatment + cognitive training (10 days). 2. Placebo: placebo + antipsychotic treatment + cognitive training (10 days). |
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Outcomes |
Usable data:
Unable to use:
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Notes | Trial registry: ISRCTN60687844. Funding: Innovative Medicines Initiative Joint Undertaking. |
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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. |