Arbabi 2012.
Methods |
Allocation: randomised.
Blindness: double‐blind.
Duration: 8 weeks. Settings: inpatients. Design: parallel. Country: Iran. Study dates: January 2008 to January 2011. |
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Participants |
Diagnosis: schizophrenia (DSM‐IV‐TR). N = 46. Age: ˜34 years. Sex: 31 M ,11 F. History: minimum score of 60 on the PANSS, length of illness 86 to 96 months. |
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Interventions |
1. Modafinil: modafinil 200 mg (100 mg mid‐morning and evening) + risperidone 6 mg/day. 2. Placebo: placebo + risperidone 6 mg/day. Participants were allowed to take biperiden for the management of extrapyramidal symptoms. |
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Outcomes |
Usable data:
Unable to use:
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Notes | Iranian Clinical Trials Registry (IRCT138903131556N16). Funding: Tehran University of Medical Sciences. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomized to receive modafinil or placebo in a 1:1 ratio using a computer‐generated code and the randomization was stratified by site." |
Allocation concealment (selection bias) | Low risk | "The assignments were kept in sealed opaque envelopes until data analysis." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Throughout the study, the person who administered the medications, the rater and the patients were blind to assignments." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Throughout the study, the person who administered the medications, the rater and the patients were blind to assignments." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis was done. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported. |
Other bias | Low risk | We found no other bias. |