Trial of OnabotulinumtoxinA for Depression in Parkinson Disease

Inclusion Criteria:

• Written informed consent is obtained in the English language;
• They are a 18 to 95 years old;
• They meet United Kingdom Brain Bank Criteria for probable idiopathic Parkinson disease;
• They meet Diagnostic and Statistical Manual (DSM)-IV criteria for major depressive disorder (MDD) as diagnosed by the M.I.N.I. at screening;
• 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 onabotulinumtoxinA injected into the facial muscles for any reason in the 3 months prior to screening;
• They have Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening;
• They endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening;
• They have a history of substance abuse or dependence in the 2 months prior to screening;
• They test positive for illicit drugs on urine screen, and this has not been adequately explained to the satisfaction of the investigator
• They are considered to be at significant risk of committing homicide;
• They have an unstable medical condition;
• Women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study;
• There has been a change in their PD medication or psychotherapy treatment regimen in the 30 days preceding screening;
• They are regarded, for any reason, by the principal investigator as being an unsuitable candidate for the protocol.