Efficacy Study of Botox for Depression
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Controlled Study of the Efficacy of Botulinum Toxin A (Botox) for the Treatment of Major Depressive Disorder (MDD)|
- MADRS [ Time Frame: Patients will be followed for up to 10 weeks ] [ Designated as safety issue: No ]Efficacy will be assessed using: the Montgomery-Asberg Depression Rating Scale (MADRS) screening, visit 2 and discontinuation
- Beck Depression Inventory [ Time Frame: Patients will be followed for up to 10 weeks ] [ Designated as safety issue: No ]Efficacy will be assessed using the patient-rated Beck Depression Inventory II (BDI) at screening, visit 2 and discontinuation.
- CGI-I [ Time Frame: Patients will be followed for up to 10 weeks ] [ Designated as safety issue: No ]Efficacy will be assessed using the Clinical Global Impression-Improvement (CGI-I) at visit 2 and discontinuation
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Botox
The study will be divided randomly into two groups of equal number; one arm will receive a Botox injection; the other will receive saline solution injection
Appropriate patients will randomly receive 29 units of Botox or a saline solution injected in to the procerus and corrugator supercilii frown muscles.
Placebo Comparator: Saline Solution
A saline solution will be injected in to the procerus and corrugator supercilii frown muscles of randomly chosen study participants.
Drug: Saline Solution
29 units of saline solution will be injected in to the procerus and corrugator supercilii frown muscles of randomly chosen study participants.
Show Detailed Description
|United States, Maryland|
|Chevy Chase Cosmetic Center|
|Chevy Chase, Maryland, United States, 20815|
|Capital Clinical Research Associates, LLC|
|Rockville, Maryland, United States, 20852|
|Principal Investigator:||Joshua Z Rosenthal, MD||Capital Clinical Research Association|