The Treatment of Depression With Botulinum Type A Toxin
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: botulinum toxin type A neurotoxin complex; Placebo
Intervention description: 29-40 U injection; 29-40 U 0.9% NaCl injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: botox; depression

Summary:

      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.
    

Eligibility criteria:

        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.