Efficacy Study of Botox for Depression
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|ClinicalTrials.gov Identifier: NCT01556971|
Recruitment Status : Unknown
Verified March 2012 by Capital Clinical Research Associates, LLC.
Recruitment status was: Active, not recruiting
First Posted : March 19, 2012
Last Update Posted : March 19, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depression||Drug: Botox Drug: Saline Solution||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Controlled Study of the Efficacy of Botulinum Toxin A (Botox) for the Treatment of Major Depressive Disorder (MDD)|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2012|
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.
- MADRS [ Time Frame: Patients will be followed for up to 10 weeks ]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 ]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 ]Efficacy will be assessed using the Clinical Global Impression-Improvement (CGI-I) at visit 2 and discontinuation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556971
|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|