The Treatment of Depression With Botulinum Type A Toxin (Botox): A Randomized, Double Blind, Crossover Study
| City: |
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Austin |
| State: |
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Texas |
| Zip Code: |
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78705 |
| Conditions: |
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Depression |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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 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.
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| NCT ID: |
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NCT01392963 |
| Primary Contact: |
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Principal Investigator
Michelle Magid, MD
Seton Family of Hospitals
Poppy E Poth
Phone: 512.324.1000 ext. 89612
Email: botoxfordepression@gmail.com
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| Backup Contact: |
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Araceli Guzman
Phone: 512.324.3380
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| Location Contact: |
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Austin, Texas 78705
United States
Poppy E Poth
Phone: 512-324-1000
Email: botoxfordepression@gmail.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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