OBJECTIVE: To examine the efficacy and safety of modafinil on parkinsonism and 
excessive daytime sleepiness (EDS), as well as on negative symptoms and 
cognitive abilities in patients with schizophrenia or schizoaffective disorder 
(DSM-IV criteria) in a randomized double-blind placebo-controlled 8-week study.
METHODS: Twenty-four male patients, who were aged 20-63 years and on stable dose 
of second generation antipsychotic medications and with a negative symptom score 
of ≥ 20 on the Positive and Negative Syndrome Scale (PANSS), were randomized 
into either the modafinil (n=12) or placebo (n=12) group. The modafinil group 
received flexible does of modafinil 50-200mg/day. Primary measurements were the 
Simpson-Angus Scale (SAS) for extrapyramidal side effects (EPS), the Epworth 
Sleepiness Scale (ESS), the PANSS and a neuropsychological (NP) test battery. 
Data were collected on Days 0, 14, 28, 42 and 56 for rating scales, and on Days 
0, 28 and 56 for NP tests.
RESULTS: Mixed model analyses showed a significant group-x-time interaction for 
total SAS scores (P<0.006), with scores decreasing in the modafinil group but 
remaining the same in the placebo group. There were no significant group-x-time 
interactions for scores of ESS (total), PANSS (total, positive and negative), 
and NP tests (composite and domains) (all P's>0.5). No significant adverse 
events were observed.
CONCLUSION: The data suggest that modafinil was a safe adjunctive treatment 
which improved parkinsonian symptoms and signs in patients with schizophrenia or 
schizoaffective disorder. Further studies in larger samples and with longer 
study time are needed to test/confirm the beneficial effects of modafinil on 
motor function.