The Treatment of Depression With Botulinum Type A Toxin
The Treatment of Depression With Botulinum Type A Toxin
A 24-week Randomized, Double-blind study treating people who suffer from depression who also
 have moderate to severe frown lines in forehead region with Botox injections. Subjects
 participating will have their photos taken and complete a questionnaire regarding their
 depression. They will see a psychiatrist at every visit who will assess their depression.
Participants will be assigned to receive either placebo or botulinum toxin injections in the
 forehead
Inclusion Criteria:

 1. Male/Female between the ages of 18 and 65

 2. Major Depression Disorder as defined by DSM IV criteria and diagnosed by a
 psychiatrist. DSM (Diagnostic and Statistical Manual) IV criteria for depression are:
 a depressed mood or anhedonia for at least a two week period. This mood must represent
 a change from the person's normal mood; social, occupational, educational or other
 important functioning must also be negatively impaired by the change in mood. Major
 depressive disorder cannot be diagnosed if a person has a history of bipolar disorder
 or if the depressed mood is better accounted for by substance abuse or a psychotic
 disorder. In addition, the patient must have 5 of the following symptoms:

 -  Significant weight loss or weight gain.

 -  Insomnia or hypersomnia

 -  Psychomotor agitation or retardation

 -  Feelings of worthlessness or excessive guilt

 -  Poor Concentration

 -  Fatigue or loss of energy

 -  Suicidal thoughts

 3. History of depression for at least 6 months

 4. Initial score 14 or higher on initial Hamilton Depression rating scale.

 5. Melancholic facial expressions amenable to treatment with Botox. Photos will be taken
 of potential participants and ranked independently by two investigators, on a scale of
 1-10 based on how negative they look, 10 being the highest. Patients with an average
 score of 6 or above will be included in the study

 Exclusion Criteria:

 1. Active substance abuse

 2. Bipolar Depression

 3. Subjects who are pregnant, nursing or trying to become pregnant during study
 participation

 4. Subjects who are currently on more than 3 psychiatric medications at the time of
 enrollment

 5. Current medications used to treat depression must be stable for at least 60 days prior
 to enrollment

 6. Previous Botox treatment

 7. The Principle Investigator has determined that this study is not in the best interest
 of the subject and therefore the subject will not be enrolled.