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

Freudenreich 2009.

Methods Allocation: randomised.
 Blindness: double‐blind.
 Duration: 8 weeks.
Settings: outpatients.
 Design: parallel.
Country: USA.
Study dates: September 2003 to September 2007.
Participants Diagnosis: schizophrenia or schizoaffective disorder (DSM‐IV).
N = 37.
Age: ˜45 years.
Sex: 27 M, 8 F.
History: treated with clozapine, length of illness 18 to 20 years.
Interventions 1. Modafinil: modafinil (flexible dose 50 mg to 300 mg) + clozapine.
2. Placebo: placebo + clozapine.
Outcomes Usable data:
  1. Mental state: worsening psychosis.

  2. Leaving the study early.

  3. Adverse effects: requiring discontinuation from the trial, clinically important adverse events (dizziness, abdominal pain, depression, headache, fatigue).

  4. Service utilisation: hospital admission.


Unable to use:
  1. Mental state: PANSS, SANS (unable to impute ‐ data were presented in units not usable in a meta‐analysis).

  2. Cognitive function: COGBAT (unable to impute ‐ data were presented in units not usable in a meta‐analysis).

  3. Adverse effects: movement disorder: ESS, FSS (unable to impute ‐ data were presented in units not usable in a meta‐analysis).

Notes Trial registry: NCT00573417.
Funding: Cephalon Inc (modafinil manufacturer).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomly assigned." Comment: probably done.
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk "Double blind" Comment: Probably done.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk "Double blind" Comment: Probably done.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 6/18 (33%) in the placebo group did not complete the study.
Selective reporting (reporting bias) High risk Continuous data were presented as a slope, so we were unable to impute the information in the meta‐analysis.
Other bias Low risk We found no other bias.