drugset / Trial / NCT01556971

Efficacy Study of Botox for Depression

NCT01556971

Phase 4 Unknown 60 enrolled Capital Clinical Research Associates, LLC
RandomizedSingle-groupDouble-blindTreatment

Summary

The objective of this proposed study is to obtain data on the efficacy of Botox in reducing symptoms of MDD in male and female patients between the ages of 18 and 65 years old. The secondary object is to visually assess each patient's frown before and after the Botox injection to determine if there is a correlation between changes in the frown and changes in mood. The patients will be photographed at screening, visit 2 and 3. Their frown lines will be compared to determine if there is a visible improvement in the frown lines corresponding to an improvement in the efficacy rating scores.

Timeline

Start
2011-02
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 29 iu Intramuscular