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:
Unable to use:
|
|
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. |