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

Shafti 2016.

Methods Allocation: randomised.
 Blindness: double‐blind.
 Duration: 8 weeks.
Settings: inpatients.
 Design: parallel.
Country: Iran.
Study dates: unclear.
Participants Diagnosis: schizophrenia (DSM‐V).
N = 50.
Age: ˜40 years.
Sex: male.
Length of illness: ˜12 years.
History: chronic, high negative symptoms score.
Interventions 1. Modafinil: modafinil 200 mg + haloperidol (5 to 10 mg).
2. Placebo: placebo + haloperidol (5 to 10 mg).
Outcomes Usable data:

  1. Mental state: no clinically important response in negative symptoms.

  2. Mental state: SAPS.

  3. Mental state: SANS.

  4. Leaving the study early.

  5. Global state: CGI‐S.

  6. Quality of life: PGWBI.

  7. Behaviour: NOSIE.


Unable to use:

  1. Adverse events: SAS (skewed data).


Not used in this review:

  1. Mental state: negative symptoms response: affective blunting, avolition‐apathy, anhedonia‐asociality; attention deficit (see Data collection and analysis, Section 2.2 Scale‐derived data).

  2. Schedule for assessment of insight.
Notes No clinical trial registry.
Funding: unclear.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk “Randomly allocated.”
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "The placebo and modafinil tablets had the same shape and color to make it difficult for the patients and the physician to differentiate them from each other."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "The placebo and modafinil tablets had the same shape and color to make it difficult for the patients and the physician to differentiate them from each other."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk "While patients were free to withdraw from the study at any stage without prejudice, there was no dropout in the course of the evaluation in any of the groups."
Selective reporting (reporting bias) Low risk Outcomes reported in the methods section are adequately reported in the results.
Other bias Low risk We found no other bias.