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

Arbabi 2012.

Methods Allocation: randomised.
 Blindness: double‐blind.
 Duration: 8 weeks.
Settings: inpatients.
 Design: parallel.
Country: Iran.
Study dates: January 2008 to January 2011.
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.
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.
Outcomes Usable data:
  1. Leaving the study early.

  2. Adverse event: any adverse event.

  3. Specific adverse events: nausea, insomnia, dizziness, headache, tremor, drowsiness, sedation, weight gain, sexual dysfunction.


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

  2. Adverse effects: extrapyramidal symptoms rating scale (unable to impute data, authors did not respond)

Notes Iranian Clinical Trials Registry (IRCT138903131556N16).
Funding: Tehran University of Medical Sciences.
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.