Efficacy Study of Botox for Depression

Inclusion Criteria:• Written informed consent is obtained;

• They are a 18 to 65 years old;
• They meet DSM-IV criteria for MDD as diagnosed by the MINI at screening, and, their current episode must be at least one month in length;
• They have a MADRS score of ≥ 26 at screening;
• They have ≥ 4 on the CGI-S at screening
• Women of childbearing potential (WOCBP) are on an acceptable form of birth control and are not pregnant or lactating;
• They are judged by the investigator to have the capacity to understand the nature of the study;
• They are willing to comply with all the requirements of the study.
• They are considered by the investigator to be likely to adhere to the protocol.

Exclusion Criteria:• They have been treated with botulinum toxin A in the 12 months prior to screening;

• They have another Axis I disorder as a principal diagnosis in the 6 months prior to screening;
• They have a history of substance abuse or dependency in the 2 months prior to screening (recreational use of illicit drugs may be permissible, at the discretion of the investigator);
• They test positive for illicit drugs on urine drug screen, and this has not been adequately explained to the satisfaction of the investigator;
• They endorse MADRS item 10 (suicidal ideas) at a level of 5 or more or have attempted suicide in the six months prior to screening;
• They are considered to be at a significant risk of committing homicide;
• They have an unstable medical condition;
• Women of childbearing potential (WOCBP) who are pregnant or are considering becoming pregnant during the length of the study;
• They are regarded, for any reason by the principal investigator as being an unsuitable candidate for the protocol.
• There has been a change in their medication or psychotherapy treatment regimen in the month preceding screening;
• They have proved to be refractory to three or more adequate antidepressant treatments with methods that have different mechanisms of action.