Alcohol Dependence - Interim Results of a Clinical Trial
16 August, 2011
Further to that stated in Brainsway's periodic report for 2010 regarding the double-blind safety and efficacy trial of Brainsway's device for the treatment of alcohol dependence, which was performed by Advanced Technologies Innovation Distribution SRL (“Atid”) in Italy, the Company is pleased to announce the interim results obtained from 13 patients (out of the 30 who are expected to take part in the trial). The principal investigator of the trial is Prof. Mauro Ceccanti of the Sapienza University of Rome, Italy.
Analysis of the interim results indicates that Deep TMS therapy is safe and effective for the treatment of alcohol dependence.
The effects of treatment were assessed by comparing pre- and post-treatment alcohol consumption measured using accepted scales. In addition, salivary cortisol levels were measured before and after treatment.
Subjects were divided into two groups. A marked and statistically significant reduction in alcohol consumption was observed in the treatment group following Deep TMS treatment, but not following sham control treatment. Furthermore, whereas salivary cortisol levels were significantly reduced in the treatment group, they tended to increase in control subjects. Cortisol levels are a biological index of anxiety and craving for alcoholic beverages in alcoholic patients, and increased cortisol levels are correlated with relapse to alcohol use during withdrawal.
In light of these positive results, the researchers propose that the trial be facilitated and potentially expanded to additional clinical sites, in order to strengthen and extend its findings.